Engineer II, Process

Recruiter: Spencer Gregory Hale

Process Engineer II

About the Role:

• The candidate must be highly motivated and driven to solve technical/complex problems in both a hands-on manner and team setting, working in a fast-paced environment, and across multiple functions in a global company.
• Uses technical and collaboration skills alongside passion for innovation and continuous improvement to drive growth through efficient and effective commercialization of new products and targeted improvements.
• The successful candidate for this position will provide strong leadership and problem solving to enable medical device innovation.
• This position offers the opportunity to support process development and product commercialization throughout Boston’s global plant network.
• Works cross-functionally to lead process development of complex technologies on new products, drive/develop new business activities and rapid prototyping execution and ensures efficient and effective transfer of product into production.

Your Responsibilities Will Include:

• Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
• Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
• Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
• Partners with R&D to develop design specifications, test methods, and material selection
• Provides Design for Manufacturability (DFM) input to the engineering print package.
• Prepares and presents technical data and recommendations at technical reviews.
• Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.)
• Writes and reviews validation protocols and reports applicable to new processes.
• Oversees development builds associated with the project using special work requests.
• Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
• Proposes or investigates new technologies
• Contributes ideas to or generates Intellectual Property submissions.

What We’re Looking For In You:

Minimum Qualifications

• BS in Engineering and 2-4 years of experience
• Strong mechanical aptitude, conflict resolution and problem-solving skills.
• Demonstrated ability to develop and drive innovative solutions into processes and products.
• Demonstrated cross functional teamwork in technically demanding environment.
• Strong communications and time management skills.
• Open to travel up to 10% of time.

Preferred Qualifications

• Experience developing and characterizing various types of processes.
• Experience with Catheter assembly.
• Demonstrated use of DFSS tools (DOE, problem solving).
• Demonstrated ability to develop equipment/fixtures/tooling from concept to production.
• Experience with mechanical design.
• Strong understanding of statistics and proficiency in Minitab.
• Medical device or other regulated industry experience.

Requisition ID: 562426