*******LOCAL CANDIDATE ONLY ****NO C2C CANDIDATES*************
Job title -Manufacturing Automation Engineer
Location - Westbrook, ME ( fully onsite)
Pay Rate : 75k/Ann- 85k/Ann
Job id #Sedaa - 45717
The position of Senior Manufacturing Automation Engineer is within our Infectious Disease Developed Markets Business Unit located in Scarborough, Maine. This role will be responsible for supporting manufacturing processes, quality/cost savings initiatives and implementation of engineering principles while assuring compliance with cGMP quality and safety standards.
This job description will be reviewed periodically and is subject to change by management.
- Carries out duties in compliance with established business policies and procedures.
- Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
- Support department by performing related tasks as requested.
- Responsible for equipment specification, acquisition, and implementation.
- Leads automation equipment upgrade efforts related to safety, obsolescence, and continuous improvement initiatives.
- Evaluates machine logic, electromechanical and process controls to troubleshoot equipment and drives to resolution.
- Leads teams to identify root cause of manufacturing failures using structured problem solving. Applies root cause fixes to prevent recurrence.
- Conducts failure modes and effects analysis and evaluates manufacturing equipment risk.
- Completes complex projects based on comprehensive knowledge of manufacturing equipment and processes.
- Leads design of experiments, validation, completion of testing and analysis of data. Presents data to cross functional teams.
- Drives implementation of new methods or materials for continual improvement of quality and efficiency.
- Analyzes current equipment for process suitability and provides detailed plans for improvement.
- Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient, and safe procedures.
- Leads other engineers and technicians in developing solutions and improvements in materials, equipment, and process as necessary in addition to ensuring continual improvement, safety, and compliance.
- Manages cross functional project teams and coordinate activities.
- Provides training and process expertise for product processing in specific areas such as process development, tooling development, documentation, cleaning protocol, process characterization and validation.
- Initiates and leads to resolution of Quality Incidents and CAPA.
- Participates in teams as necessary and mentors junior engineers and maintenance technicians to ensure continual improvement, safety, and compliance.
- Considers safety, ergonomic, maintenance, and operator impact on manufacturing design.
- Interacts with the local Project Management Office on milestones and project status updates.
- Participates in site strategy meetings and planning.
- Leads change through Agile PDM.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
- 7+ years engineering experience in a manufacturing environment.
- Experience in the application of lean six sigma principles and the DMAIC approach or a similar structured problem-solving system.
- Proficiency in change management principles and processes.
- Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations.
- Experience working in a GMP, FDA, ISO and USDA regulated environment.
- Experience in cGMP and ISO 13485 regulations and practices.
- Experience in statistical analysis software.
- Experience in Microsoft Suites software (Microsoft Excel, PowerPoint, Power BI, etc.).
- Innovative Thinking: Independently generates new, creative, and sometimes unconventional ideas to problem solve or improve current processes and structures while seeking feedback from managers and coworkers.
- Multitasking: Demonstrates the ability to handle multiple tasks or responsibilities simultaneously by efficiently managing time, prioritizing tasks, and maintaining productivity across different activities.
- Self-Motivated: Demonstrates a proactive attitude, consistently drives personal and team goals, and maintains high productivity with minimal external supervision.
- Verbal and Written Communication: Effectively conveys ideas in both individual and group settings, adapting style and methods to suit the audience’s needs, both verbally and in writing.
- Teamwork and Collaboration: Demonstrates professional cooperation by working together harmoniously with others, being an integral part of a team, respecting others’ contributions, and aligning personal goals with those of the team.
- Fabrication Principles: Proficiency in fabrication principles including CNC, lathe, milling, welding, and bolted connections.
- Mathematical Aptitude: Proficiency in mathematical concepts such as ANSI/AQL, probability, and statistics.
- Technical Aptitude: Proficiency in the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- CAD: Experience in computer-aided design (CAD) and manufacturing software for designing system layouts.
- Materials Testing: Proficient in a variety of testing and measuring methods relating to the process of evaluating the properties and performance of materials used in manufacturing.
*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO Minnetonka, MN****NO C2C CANDIDATES*************
Job title -Manufacturing Engineer
Location - Minnetonka, MN (on-site role)
Pay Rate : 40-55k/Ann
Job id - Sedaa 44324
This position is Non-Exempt. Hours over 40 will be paid at Time and a Half.
DUTIES AND RESPONSIBILITIES:
- Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company's environment to take an effective and proactive leadership role in a specific technical manufacturing discipline.
- Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks tasks that may have multiple inter-coordinating elements.
- Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required. Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components. Interaction with peers and mentors on the individual projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.
QUALIFICATIONS:
Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering. The individual will typically have had a minimum 2-5 years experience in an engineering discipline or advanced education to achieve the level of skill.
EXPERIENCE AND SKILLS:
-
Medical device experience and ISO/GMP training an advantage. Knowledge of Microsoft based computer software programs. Must be a team player. Good attention to detail. Must be able to lift 50 lbs. Must be able to sit/stand for 2 to 3 hours at a time.
*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO Minnetonka, MN****NO C2C CANDIDATES*************
Job title -Manufacturing Engineer
Location - Saint Paul, MN (100% on-site role)
Pay Rate : 40k/Ann- 58k/Ann
Job id - Sedaa 44365
Description:
This position works out of our Minnetonka MN location in Electrophysiology (EP) business.
Individuals in this role will work on a new product launch supporting the operations team as a 1st shift Manufacturing Engineer working with assemblers, and leading technicians on troubleshooting equipment and investigating process issues. Additionally, this position will support projects aimed towards designing and developing manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality. This individual will have a unique opportunity to make a mark on the organization, while working on state-of-the-art product.
What You’ll Work On
- Front line Manufacturing Engineer supporting Operations team in a clean room environment;
- Support products which include new production equipment, process improvements and cost reductions while supporting new product introductions
- Lean manufacturing processes, techniques and best practices and support Operations team in coaching assemblers through daily activities and training certifications
- Instruct production personnel in the manufacturing and testing of product devices
- Recommend and implement process, tooling, equipment changes for improving safety, quality, delivery and cost
- Interpret test data, analyze product performance, develop summaries, and assist in the initiation of yield improvements
- Daily troubleshooting of safety, quality or process issues
- Perform scrap dissection and lead investigation into potential root causes
- Summarize information to communicate across shifts and with other functional areas, and reporting to leadership team
Individual should:
- Be innovative, resourceful, and work with minimal direction
- Have excellent organization, problem solving, communication, and collaboration skills
- Work effectively with cross-functional teams
- Exercise technical knowledge to support achievement of business objectives through launch of the product, volume ramp and yield improvement, which will require setting direction, leading, and taking ownership of complex manufacturing engineering technical tasks with multiple inter-coordinating elements
- Anticipate and identify key issues, understand impact and make recommendations for resolution which remain compliant with Quality System requirements
- Obtain peer review and manager review to confirm rationale for the approach is appropriate
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Enironmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Shift (Beginning)
1st Shift: Mon - Thurs, Approximately 5:00AM – 3:30 PM
(precise times may be shifted to accommodate other shift schedules, early shift support or other project work)
This position will begin as a 1st shift role but may later switch to second shift (3:30PM - 2:00AM). Ideal candidate will be able to flex across both shifts for training, cross-shift coverage when needed or alignment for future line support needs. Candidates who cannot flex will still be considered, however the ability to flex is a strong plus. Additionally, while shifts are 10hrs, Mon-Thurs, there is a strong opportunity for Overtime on Fridays & Saturdays and ability to support is desired.
Required Qualifications
-
The individual will typically have had 2-5 years experience in an engineering discipline or advanced education to achieve the level of skill. Bachelor Science or Bachelor Engineering in Electrical, Mechanical or Biomedical Engineering or similar is desired. Curriculum training will be provided to ensure understanding of Quality System requirements required to perform assignments. This position is NonExempt. Hours over 40 will be paid at Time and a Half.
*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO Saint Paul, MN****NO C2C CANDIDATES*************
Job title -Manufacturing Engineer
Location - Saint Paul, MN (100% on-site role)
Pay Rate : 40k/Ann- 62k/Ann
Job id - Sedaa 44210
Description:
Selected Candidate will start ASAP after screenings have cleared.
Top Skills:
- Excellent documentation skills
- High attention to detail
- General mechanical engineering knowledge with the ability to quickly step into the initiative after training
- Excellent documentation and execution skills
- Education: Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering.
- Experience: 3-5 years Prior experience preferred
WHAT YOU’LL DO
- Review documentation of procedures and ensure proper execution of protocols and SOPs as part of the site’s integration into Client.
- Support the maintenance of controlled process documentation, including work instructions, process flow diagrams, gap analysis, control plans, and risk‑management documentation.
- Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company's environment to take an effective and proactive leadership role in a specific technical manufacturing discipline.
- Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks that may have multiple inter-coordinating elements.
- Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required.
- Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components.
- Interaction with peers and mentors on the individual's projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.
*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO PLYMOUTH, MN****NO C2C CANDIDATES*************
Job title -Manufacturing Engineer
Location - Austin, TX (100% on-site role)
Pay Rate : 40k/Ann- 68k/Ann
Job id - Sedaa43310
Description:
Key Responsibilities
- High Priority: Plan, implement, and manage engineering projects for automated assembly lines, including development, build, testing, commissioning, and validation.
- High Priority: Manage complex automation engineering projects and new product development across multiple global sites
- Drive activities with equipment suppliers to ensure successful production start-up and scale-up.
- Lead design, planning, and sustaining of automated manufacturing systems.
- Ensure adherence to quality, regulatory, and corporate standards; report progress against timelines.
- Identify and escalate risks impacting project delivery, product quality, or safety.
- Interface with cross-functional teams including R&D, Quality, Regulatory, and Operations.
- Develop and implement innovative solutions and manage engineering changes.
- Conduct complex engineering studies, analyze data, and prepare technical reports.
- Create process documentation and technical procedures for medical device equipment.
- Perform root cause analysis and implement corrective actions for yield and cycle time issues.
- Travel up to 10% (primarily Europe and U.S.) for project-related activities.
High Priority Qualifications:
- Prior experience in medical device or pharmaceutical environments (FDA/cGMP/ISO regulated).
- Strong knowledge of automation systems, validation lifecycles, and high-volume manufacturing lines.
- Excellent project management, communication, and problem-solving skills.
Qualifications:
- Bachelor’s degree in Engineering/Manufacturing or related discipline (Automation/Electronics/Mechatronics preferred).
- Minimum 5+ years of progressive technical experience; experience with automated manufacturing processes preferred.
- Ability to work independently and in a fast-paced, team-oriented environment.
- Familiarity with equipment software, pneumatics, electronics, vision systems, lasers, and GAMP guidelines.
*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO PLYMOUTH, MN****NO C2C CANDIDATES*************
Job title -Manufacturing Engineer - I
Location - Pomona, California (100% on-site role)
Pay Rate : 30k/Ann- 40k/Ann
Job id - Sedaa42880
Description:
This position is Nonexempt. Hours over 40 will be paid at Time and a Half.
- Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company?s environment to take an effective and proactive leadership role in a specific technical manufacturing discipline.
- Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks ? tasks that may have multiple inter-coordinating elements.
- Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required.
- Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components.
- Interaction with peers and mentors on the individual?s projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.
Education:
- Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering.
- Curriculum trains students in skills required to perform assignments.
- 0-3 years exp
*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO PLYMOUTH, MN****NO C2C CANDIDATES*************
Job title -Manufacturing Engineer
Location - Plymouth, MN ( (100% on-site role)
Pay Rate : 40k/Ann- 60k/Ann
Job id - Sedaa43048
Description:
Non-Exempt position.
Looking for 1 individual with an engineering background to support 1st shift medical device (catheter) production. The day-to-day for this role involved providing direct production support on the manufacturing floor – working with operators, investigating yield issues and catheter scrap, and collaborating with other functional teams to promote a strong operations environment.
- 1st shift role ( 5:30 AM - 3:30 PM, Monday –Thursday) – some flexibility with coverage
- Front line engineer
- Direct production support in clean room 80%+ of day
- Responds to escalations from Operations (e.g. scrap, quality issues, process questions/suggestions, equipment errors)
- Building relationships and coaching Operators
- Scrap dissection and yield improvement
- Basic equipment troubleshooting
- Participate in ergonomic safety projects
Background/Qualifications –
Required:
- Local candidate (100% on-site role in Plymouth, MN)
- Bachelor’s degree in engineering
- Soft Skills
- Strong verbal and written communication skills are a must
- Proactive / motivated and can work independently
- Patience with varying personalities and cultures
Preferred/Nice to Have:
-
0-3 years of relevant experience
- Direct production support (front line, day-to-day hands-on experience)
- Prior medical device experience
- Internship experience, hands-on experience preferred
- TA work, tutoring, babysitting experience nice to have as it demonstrates coaching / teaching ability
*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO PLYMOUTH, MN****NO C2C CANDIDATES*************
Job title -Manufacturing Engineer
Location - Plymouth, MN ( (100% on-site role)
Pay Rate : 40k/Ann- 60k/Ann
Job id - Sedaa43047
Description:
Looking for 2 individuals with an engineering background to support 2nd shift medical device (catheter) production. The day-to-day for this role involved providing direct production support on the manufacturing floor – working with operators, investigating yield issues and catheter scrap, and collaborating with other functional teams to promote a strong operations environment.
- 2nd shift role (4 PM – 2 AM, Monday –Thursday) – some flexibility with coverage
- Front line engineer
- Direct production support in clean room 80%+ of day
- Responds to escalations from Operations (e.g. scrap, quality issues, process questions/suggestions, equipment errors)
- Building relationships and coaching Operators
- Scrap dissection and yield improvement
- Basic equipment troubleshooting
- Participate in ergonomic safety projects
Background/Qualifications:
Required:
- Local candidate (100% on-site role in Plymouth, MN)
- Bachelor’s degree in engineering
- Soft Skills
- Strong verbal and written communication skills are a must
- Proactive / motivated and can work independently
- Patience with varying personalities and cultures
Preferred/Nice to Have:
-
0-3 years of relevant experience
o Direct production support (front line, day-to-day hands-on experience)
- Prior medical device experience
- Internship experience, hands-on experience preferred
- TA work, tutoring, babysitting experience nice to have as it demonstrates coaching / teaching ability
*******LOCAL CANDIDATE ONLY OR OPEN TO RELOCATE TO PLEASANTON, CA****NO C2C CANDIDATES*************
Job title -Manufacturing Engineer - Labeling and Packaging
Location - Pleasanton, CA ( fully onsite)
Pay Rate : 50k/Ann- 80k/Ann
Job id - Sedaa
Our client is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 150 countries.
JOB DESCRIPTION:
Leading an active lifestyle is important to the many people we serve. In Client's Heart Failure division, we’re advancing the treatment of heart disease through breakthrough medical technologies in heart failure, allowing people to restore their health and get on with their lives.
We are seeking an experienced, high caliber Manufacturing Engineer onsite at our Pleasanton, CA location. This position will support labeling and packaging manufacturing processes in order to meet program milestones for the Labeling and Packaging Engineering team in the Heart Failure division.
WHAT YOU’LL DO
- Drive projects related to labeling or packaging initiatives including scheduling and leading cross functional reviews.
- Execute change orders in the Windchill product lifecycle management software impacting manufacturing process documentation, product BOM structure, product/component specification changes & improvements
- Update manufacturing, packaging, and labeling processes to meet production demands while enhancing productivity and product quality.
- Support equipment maintenance and resolve production downtime for label printers and heat-sealing packaging equipment.
- Design and release labeling specifications. Lead label cross functional reviews to gather all pertinent information in compliance with Client and recognized regulatory standards.
- Author process validation protocols and reports. Including but not limited to equipment IQ, process OQ, process PQ, and product PPQ.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
- Bachelor's of Science degree in Mechanical, Industrial, or Electrical Engineering, or equivalent
- Minimum 3 years of relevant engineering experience
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Multitasks, prioritizes and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
Preferred:
- Previous experience in label design work, with preference in any of the following labeling design systems: Bartender, enlabel, Integration with SAP ERP systems.
- Design experience in the Adobe Acrobat Create Suite, namely Adobe Illustrator, InDesign, and/or Photoshop.
