NPI Engineer- Med Device- Marlborough, MA

The NPI Engineer is responsible for transitioning new medical device projects from early development into controlled manufacturing, focusing on process development, assembly design, and documentation. This role involves collaborating with cross-functional teams, optimizing processes, and mentoring junior engineers while ensuring compliance with industry standards.

Client Details

Our client is a prominent organization in the medical device industry, known for its commitment to innovation and advanced manufacturing techniques. They prioritize a dynamic work environment that fosters employee growth and collaboration, driving excellence in product development and engineering solutions.

Description

• Design assembly and test fixtures with minimal oversight and implement Design for Assembly (DFA) improvements on complex medical device assemblies.
• Assist in validation and qualification studies for complex medical device assemblies.
• Identify and implement line balancing and process optimization activities with little supervision.
• Understand best practices for formatting Manufacturing Process Instructions and provide effective training on medical device assembly processes.
• Work through complex problems independently, with some input from senior colleagues.
• Gain experience in multiple development phases guided by Design Controls requirements, demonstrating familiarity with Quality SOPs.
• Understand ISO 13485 sufficiently to participate in audits and guide junior engineers.
• Develop a functional technical and clinical understanding of current products and broaden technical process expertise.
• Author single-phase proposals and project timelines with guidance, participating in client calls as a secondary technical resource.
• Work under minimal supervision, taking responsibility for completing assigned tasks.
• Collaborate effectively on active projects by being aware of the client's technologies and facilities.
• Present content in customer meetings with team support, maintaining timely and professional communication with clients.
• Identify and report unmet customer needs related to the client's technology to the Advanced Technology Group.
• Maintain a growth mindset by actively seeking and accepting constructive feedback.
• Demonstrate leadership and mentorship by sharing knowledge and experience with colleagues, possibly mentoring co-op students.
• Complete complex tasks with minimal direction and adapt quickly to changing priorities and processes.
• Familiarize oneself with foundational process development techniques used in assembling catheter-based devices and lead troubleshooting activities as needed.
• Communicate respectfully and professionally with peers about technical and non-technical subjects.
• Present complex engineering concepts to internal and external stakeholders, considering timeliness and communication methods.
• Understand common inspection techniques used in medical device design and manufacturing, incorporating Design for Metrology principles into work.

Profile

• 3+ years of experience in the medical device design and development field.
• Proficient in Microsoft Office, including MS Teams, Excel, PowerPoint, and Outlook.
• Familiarity with ISO 13485 and 21 CFR regulations.
• Foundational skills in SolidWorks.
• A developed understanding of materials science and properties relevant to common medical device materials.

Job Offer

• Competitive base salary of $90,000- $110,000
• Strong benefit package
• Opportunities for professional development and growth

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.