What are the responsibilities and job description for the Manufacturing Engineer II position at Primary Talent Partners?
Primary Talent Partners has a 12 month contract opening for a Manufacturing Engineer II with a Medical Device client in North Haven CT.
Pay Range: $45 to $55 per hour
Full time hours, onsite role
12 months assignment with possibility of extension/conversion
W2, no sponsorship, no benefits included, no PTO. No relocation assistance.
Contractor Healthcare Benefits available for enrollment.
The ME will be responsible for validating and qualifying new packaging materials (foil, Tyvek, film) for absorbable suture products. The ME will be responsible for process development activities and creating the validation plans in compliance with company standards. The ME will be the project lead and communicate project deliverables and timing to engineering management.
Top 3 technical skills that are required for the role:
- Packaging Experience
- Validation Experience - Process Development, OQ, IQ, PQ
- Familiarity with Cognex and Keyence based vision inspection systems
What product line will this person support? Validating and qualifying new nylon film for our absorbable suture products.
Job Responsibilities:1. Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA (International Safe Transit Association) standards.
2. Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO 11607 2 (Part 2: Validation requirements for forming, sealing and assembly processes). These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
3. Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices'
Required Knowledge and Experience:
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Education Required: BS (or above) Engineering Degree; Mechanical, Manufacturing, Packaging
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
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Salary : $45 - $55
