Senior NPI Design Transfer Engineer (Hybrid- Acton, MA)

Insulet Corporation•Acton, MA

1d•Hybrid

About The Position

We are seeking a highly skilled and detail-orientated New Product Introduction (NPI) Design Transfer Engineer to join our team. As a crucial part of our product development and manufacturing teams, the Senior NPI Design Transfer Engineer will be responsible for effectively transferring new product design from development phase to full scale production. The ideal candidate should have a strong background in disposable and/or wearable medical devices and possess the ability to understand how to transfer the product design to manufacturing while ensuring compliance with applicable standards. The Senior NPI Design Transfer Engineer will be responsible for developing strategies for product identifiers (i.e. part numbers, model numbers, reference/catalogue numbers), strategies for Bill of Material (BOM)management and modeling number schemes that meet stakeholders needs and will be proactive in driving process improvements to ensure seamless compliance with regulatory requirements and applicable standards. The candidate’s experience in product design and manufacturing engineering will be essential in ensuring seamless integration and successful commercialization. The position will report to Manager, Systems Engineering and will be based in Massachusetts

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.

Nice To Haves

Demonstrated skills with managing multiple tasks, highly adaptive mindset with ability to judge and set priorities.
Extensive knowledge in diabetes management products.
Experience or formal training in established Manufacturing Engineering, Systems Engineering, and/or Mobile Application concepts.
Demonstrated skills in developing and introducing to manufacturing innovative FDA regulated medical devices in the drug delivery market.
Knowledge of Medical Device standards and regulations (ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR part 820.30-Design Controls, EU MDR).
Knowledge of international in-country standards a bonus.
Domain expertise in one of more associated domains; preferably Electrical or Software Engineering, with exposure to Manufacturing, Mechanical, Quality, and Test Engineering.

Responsibilities

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.