Guardian Medical, USA
Guardian Medical, USA is a company that specializes in creating advanced packaging solutions for medical devices. We design, develop, manufacture, and distribute sterile packaging and packaging services to ensure the safety and sterility of medical devices and implants. Our focus on innovation allows us to offer unique and efficient sterile packaging solutions to the medical industry. Our employees are the true Guardians of our customer's medical devices, ensuring their safe and sterile journey to the surgical field. With our united efforts and shared values, we are revolutionizing medical device packaging. If you are interested in taking up the shield and providing innovative packaging solutions and services to protect our customer's medical devices, please submit your application or resume for any of our open positions!
Benefits
We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees, including:
Standard Monday–Friday, first-shift work schedule
- Eight (8) paid holidays annually
- Paid sick leave
- Paid vacation time
- Medical, dental, and vision insurance
- Employer-paid basic life insurance
- Employer-paid short-term and long-term disability insurance
- Company contributions to a 401(k) retirement plan
- Employer-funded Health Savings Account (HSA) contributions each pay period
- Paid bereavement leave
- Unpaid Emergency Leave Time
- Potential relocation package for the selected candidate
Overview
The Engineering Manager is responsible for leading engineering activities within a regulated medical device manufacturing and contract packaging environment. The Engineering Manager ensures engineering projects, process changes, equipment improvements, validations, and customer onboarding activities are executed in alignment with the organization’s Quality Management System, applicable regulatory expectations, and ISO 13485-aligned practices. This role leads cross-functional teams to bring safe, effective, and reliable products and processes into production while managing technical priorities, resources, project budgets, controlled change, risk management, audit readiness, and sustained production performance.
Essential Job Duties and Responsibilities
- Oversee capital projects, equipment upgrades, process changes, and facility or manufacturing improvements from planning through implementation
- Develop, mentor, and manage engineers and technical staff to meet operational, project, quality system, and strategic business objectives while fostering accountability, innovation, and continuous improvement
- Lead technical onboarding of new medical device customers (OEMs) in a contract packaging environment, including process transfer, equipment and packaging readiness, documentation alignment, and cross-functional launch support
- Partner with customers and internal quality, operations, and packaging teams to originate and support qualifications, validation planning and approval, risk assessment, and implementation of new packaging or production requirements
- Ensure engineering activities and projects, product/process changes, and manufacturing processes meet applicable Quality Management System requirements, FDA expectations, ISO 13485-aligned practices, customer specifications, and safety and efficacy standards
- Direct validation and qualification activities for equipment, tooling, packaging processes, utilities, and process changes, including protocol/report authorization and review, execution support, deviation resolution, and final approval coordination
- Champion design transfer, process transfer, and customer product onboarding by translating customer specifications, drawings, packaging requirements, and quality requirements into reliable production processes
- Partner with Quality and Regulatory teams to create and support CAPA investigations, nonconformance reviews, complaint-related technical evaluations, supplier or material changes, and effectiveness verification when engineering input is required
- Maintain strong technical interfaces with customers, suppliers, and internal stakeholders to resolve engineering issues, clarify requirements, support audits, and ensure timely completion of launch and sustaining engineering commitments
- All other duties as assigned
Minimum Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
General
- Must be authorized to work in the U.S. on a full-time, long-term basis
- Able to read, comprehend, and speak English fluently to communicate questions, errors and production needs effectively, concisely and clearly
Knowledge / Education / Skills/Experience
- Bachelor’s degree in Biomedical, Mechanical, Packaging Engineering or related technical discipline
- 3+ years of progressive engineering experience including leadership or supervisor responsibility including performance management
- Strong knowledge of medical device Quality Management System requirements, including ISO 13485-aligned practices, FDA expectations, document control, change control, and audit readiness
- Experience implementing capital projects, process improvement, equipment or systems optimization, engineering change management, new product introduction (NPI), and lean manufacturing implementation
- Experience with medical device packaging, design controls, ISO 11607, packaging validation, and technical documentation in a regulated environment
- Experience with equipment, process, packaging, or manufacturing validation activities, including IQ/OQ/PQ, protocol/report creation and review, deviation resolution, and validation documentation
- Ability to author and support CAPA, nonconformance investigations, complaint-related technical reviews, root cause analysis, risk assessments, and effectiveness verification (Root cause analysis)
- Proven ability to lead new product introduction, process transfer, customer onboarding, production readiness, and commercial launch support in a regulated, medical device manufacturing environment
Mental/Emotional Abilities
- Demonstrated leadership experience managing engineering teams, technical staff, priorities, performance expectations, and cross-functional project execution
- Strong project management skills, including resource planning, budget awareness, milestone tracking, technical decision-making, and prioritization across multiple initiatives
- Lead projects from initiation to completion by planning, coordinating and executing all phases with attention to detail
- Excellent communication and collaboration skills with Quality, Regulatory, Operations, Maintenance, Supply Chain, customers, suppliers, and senior leadership
- Technical problem-solving and decision-making skills
Physical Abilities
- Must have the manual dexterity to perform assembly of small components and operate delicate tools
- Able to perform visual inspection of small parts and to read fine print with or without corrective lenses
- Able to lift up to 20 pounds
- Must be willing to work in a cleanroom environment and follow all protocols
- Able to bend, twist, and reach
- Able to sit for long periods of time and look at computer screen
Special Notes
- Smoking and/or vaping are not conducive to a cleanroom environment nor are the remnants of smoking/vaping particles on an individual. Therefore, Guardian has specific guidelines regarding an individual’s smoking/vaping habits.
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Preferred Qualifications
- 5+ years experience working in an ISO 13485-certified or FDA-regulated medical device manufacturing, packaging, or contract manufacturing environment
- Prior experience supporting medical device manufacturing, sterile barrier packaging (supported by ISO 11607), labeling, kitting, assembly, or cleanroom production operations preferred
- Knowledge of injection molding, extrusion blow molding, molded component manufacturing, tooling, automation, equipment design, medical packaging design and development or process development for medical device components
- Experience supporting customer onboarding, product transfer, or launch activities in a medical device contract packaging environment
- Familiarity with medical device risk management (pFMEA), design transfer, process transfer, design history files (DHR), device master records (DMR), or technical file documentation
- Lean Six Sigma, ASQ, project management, or related technical certification preferred
Working Conditions
- Indoor facility located next to an active commercial and military airport
- Air quality-controlled rooms that have strict entry protocol including the use of gowns, masks, gloves and hair nets
- Climate-controlled and clean production space and warehouse with very low noise level
- Sedentary work with extended periods of computer use
- On-site position with the potential for travel to attend conferences, visit customer/supplier facilities, and participate in training
Disclaimer: This position description is used as a basis for determining the position classification and is maintained as an official record of the duties assigned to this position. This description is intended to be an accurate reflection of the assigned work; however, it is understood that duties may be removed, modified or assigned, and may not be included in this description.
