Senior NPI Design Transfer Engineer
Diabetes Youth Families
full-time
Posted on:
Location Type: Hybrid
Location: Acton • Massachusetts • United States
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Salary
💰 $102,400 - $153,550 per year
Job Level
About the role
- Primary interface to manufacturing for all early development projects.
- Collaborate with cross-functional teams including product design, systems engineering, development, design quality assurance, labeling, regulatory, and manufacturing engineering to ensure smooth transition of new products to manufacturing.
- Support manufacturing activities, addressing any issues encountered during production.
- Develop and implement strategies for product identifiers (i.e part numbers, model numbers, reference/catalogue numbers) management, ensuring efficient and effective processes.
- Through partnering with manufacturing engineering, develop and implement strategies for BOM management at different manufacturing sites and for different international markets.
- Ownership of BOM strategies for new product introduction and transfer of design to manufacturing, including part number management, and supporting design transfer PCOs and ECOs.
- Responsible for modeling number schemes and ownership of associated procedures to develop strategies to ensure consistency.
- Communicate and collaborate effectively with internal stakeholders, including labeling design teams, systems engineering, manufacturing, supplier quality, design quality assurance, and regulatory affairs, to align processes with overall project and business objectives.
- Stay up to date with industry trends, technological advancements, and regulatory requirements to drive continuous improvement and innovation within the insulin pump and wearable medical devices industry.
- Provide guidance and support to junior engineers, promoting knowledge sharing and professional development.
- Perform other duties as needed.
Requirements
- A Bachelor of Science or equivalent degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering is required, a Master of Science degree is desired.
- A minimum of five (5) years' experience working as a New Product Introduction Engineer, Design Transfer Engineer, or R&D Engineer in a multidisciplinary project team environment.
- One (1)+ years of experience or exposure to manufacturing engineering environment for medical devices.
- In depth understanding of medical device product realization (design controls) and application of test strategies.
- Ability to work well in team environment with excellent written and verbal communication skills.
- Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
BOM managementproduct identifiers managementdesign transfermodeling number schemestest strategiesproject managementregulatory compliancequality management systemscross-functional collaborationmanufacturing engineering
Soft Skills
communicationteamworkleadershipproblem-solvingknowledge sharingprofessional developmentcollaborationorganizational skillsinterpersonal skillsadaptability