JOB SUMMARY:
Manages and leads aspects of engineering activities within organization. Ensures engineering projects, initiatives, and processes are in conformance with organization's established policies and objectives.
JOB DUTIES:
· Complies with all internal procedures and applicable regulatory requirements for medical devices.
· Ensures Change Controls are implemented and maintained per procedure. Ensures all drawings are reviewed for accuracy. Maintains and manages software and drawing controls.
· Ensure product design intent, quality and compliance through design controls and sustaining engineering efforts. Designs must be safe, effective, reliable, manufacturable, serviceable and cost effective.
· Must ensure projects meet or beat scheduled completion dates for all design and development projects (including re-design efforts) and are within budget.
· Responsible for ensuring Design Master Files are complete and in compliance with FDA, ISO, MDD and other applicable requirements.
· Implement/maintain industry level expectations for Engineering tools – Tooling/Fixturing design concepts, Tolerance Analysis, modular designs for other uses, (FMEA) Failure Mode Effects Analysis, (FEA) Finite Element Analysis, GD&T, etc.
· Reviews project requirements and provides inputs for RFQ’s and proposals.
· Supports Business Development activities as needed.
· Keeps senior/executive management abreast of limiting or significant engineering issues including safety/recall issues, impacts to product launches and deliveries, and impact to customer relationships.
· Coordinates communication with internal stakeholders throughout organization levels and supports problem solving projects/endeavors. Key external contacts include customers, experts, industry, contractors and vendors.
· Direct/support the timely resolution of all product complaints and product liability issues. Comply with State and Federal regulations. Minimize legal exposure and/or liabilities of the corporation.
· Provide feedback and consulting regarding production and inspection technical issues.
· Carries out manager responsibilities in accordance with the organization’s policies and applicable laws. Represent and cultivate company culture of collaboration and professionalism.
· Evaluates designs to develop, create, verify, and validate effective and cost-efficient manufacturing, inspection, and assembly processes that meet product specifications and requirements.
· Evaluates and troubleshoots problems, issues, or challenges in the manufacturing, inspection, and assembly processes to provide solutions.
· Must be able to perform and demonstrate all developed and existing manufacturing, inspection, and assembly processes in a general hands-on approach.
· Gathers information for analysis to provide data on existing as well as proposed manufacturing, inspection, and assembly processes for good decision making. This may include calculating production costs through labor, methods/processes, time, equipment, and materials.
· Works and collaborates with outside suppliers in acquiring information for new development requirements or in working through problems, issues, and/or challenges.
· Complies with regulations and established company policies, procedures, and processes to ensure best practices are followed that ensure all products or processes meet specifications and/or requirements.
· Serve as Technical coach and mentor.
· Be a collaborative member of the Management Team.
· Support other departments as directed by senior/executive management.
· Maintain a safe working environment.
· Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding an disciplining employees; addressing employee complaints and resolving problems.
· Attend or lead meetings as necessary as a part of team collaboration.
· Performs other duties as assigned.
SKILLS AND QUALIFICATIONS:
· Requires a bachelor's degree in engineering and a minimum of 8 years of engineering work experience with minimum 5 years in medical device field.
· Minimum of 5 years’ experience in a management or leadership role.
· Must be proficient with complex processes and elements within Design Controls such as Medical Device Regulations, Device Testing & Validation (Reliability, Usability, Medical Electrical Safety, and Sterilization/Reprocessing), Risk Management, and Design for Manufacture.
· Must be proficient in project planning, which includes creating realistic timelines utilizing Microsoft project, task and project meeting management, and driving projects to completion on time and within budget.
· Prior experience developing electro-mechanical products from concept through manufacturing and working with a production machine shop preferred.
· Design and development in regulated industries required, preferably medical device background and working knowledge of IEC 60601-x, ISO 13485.
· Experience with design controls for medical devices Title 21 CFR 820 and ISO 13485 is preferred.
· Experience with Risk Management ISO 14971 is preferred.
· Experience with 3D Solid Modeling CAD software is required – Solidworks preferred.
· Hands on experience with the development and manufacturing of small electromechanical systems/devices is preferred.
· Must be familiar with Microsoft Project.
· Experience and general understanding of operation and programming of Computer Numerically Controlled (CNC) equipment is preferred.
· Experience with Design for Manufacturability/Inspection/Assembly (DFMIA).
· Good understanding of ASME Y14.5 Geometric Dimensioning & Tolerancing (GD&T) and how it relates to the design, manufacturing, inspection, and assembly processes or procedures.
· Able to conduct tolerance stack-up analysis is required.
· Able to conduct stress analysis or analysis of the loading conditions on a design for assembly or manufacturing processes.
· Able to understand and implement principles of Lean Methodology for improvements and gain efficiencies.
· Able to apply statistical methods to analyze data for testing, manufacturing, inspection, and assembly processes. Able to gather information and data quickly and efficiently for analysis to provide direction and guidance for good decision making.
· General familiarity with IP principles.
· Must be able to lead, coach, and provide technical guidance to employees.
· Able to effect process improvement, strategic planning, and standards development.
· Relies on experience and judgment to plan and accomplish goals. A wide degree of creativity and latitude is expected.
· Must be accountable, adaptable and have a high degree of accuracy.
EDUCATION AND EXPERIENCE:
Bachelor’s degree in engineering (mechanical, electrical, or equivalent) 5-10 years’ experience as a Manufacturing Engineer within medical device industry. Advanced engineering degree a plus
LANGUAGE SKILLS:
Must possess ability to read, write, speak clearly and succinctly, and comprehend the English language. Ability to read, analyze, and interpret complex documents. Ability to respond effectively to sensitive inquiries or complaints. Ability to prepare presentations and articles using original or innovative techniques or style.
MENTAL, PHYSICAL AND VISUAL DEMANDS:
The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 50 pounds. The employee may be required to conduct inspections under magnification.
Ability to utilize a computer, telephone, fax and copy machine are required as well as other general office equipment.
We are an Equal Employment Opportunity (“EEO”) Employer. We are an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. The Company makes hiring decisions based solely on qualifications, merit, and business needs at the time
Pay: $155,000.00 - $175,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
