Product Engineer (Mechanical)

Position Responsibilities:

Common Responsibilities:

• Support and drive product transfer into manufacturing.

• Perform data trending and analysis.

• Apply FMEA, DOE, and statistical analysis to optimize product quality and reduce costs.

• Drive process improvements, cost reduction, and product sustaining activities.

• Manage Engineering Change Request and Notifications (CRs and CNs), including updates to work instructions and test requirements.

• Support documentation: engineering drawings, BOMs, test reports, assembly procedures, and validation plans.

• Participate in continuous improvement initiatives and operational excellence programs.

• Frequent cross-functional collaboration and occasional travel to other sites.

Discipline-Specific Responsibilities (Mechanical Engineering):

Design & Development

• Independently implement component/assembly changes (material, finish, tolerances).

• Perform tolerance stack-ups; define CTQs for parts.

• Draft/execute DOEs for yield/quality issues.

Manufacturing Support & NPI

• Own segment of transfer activities: golden unit builds, test setup calibration, GR&R plans.

• Qualify alternate suppliers/materials; execute PPAP/FAI with quality/manufacturing.

Quality, Reliability & Data

• Lead failure analysis on recurring defects; implement interim containment.

• Apply SPC; monitor Cp/Cpk; propose corrective/preventive actions.

• Perform basic DOE and SPC analysis for yield improvement.

• Apply root cause analysis with quantitative evidence.

• Provides charts/tables in reports rather than anecdotal statements.

• Challenges unsupported opinions with data queries.

• Communicates findings with clear visuals (Pareto, trend charts).

Project & Process

• Plan small workstreams; align deliverables with core team schedules.

• Author ECRs; manage scrap analysis and material disposition.

Documentation & Compliance

• Generate detailed drawings, BOM updates, test reports, assembly procedures, validation protocols.

• Maintain PLM integrity; traceability to requirements/design inputs.

Collaboration

• Engage suppliers/CMs for DFM feedback; support builds at CM sites.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements:

• Typically requires a Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.

• Proficiency in CAD systems (SolidWorks/Creo) with understanding of GD&T and DFMA principles.

• Working knowledge of FMEA, DOE, SPC and manufacturing processes.

• Experience using PLM systems (e.g., Teamcenter) and exposure to ERP environments (e.g., SAP/Oracle).

• Advanced competency in Excel and familiarity with statistical tools (e.g., Minitab/JMP).

• Preferably experienced in life sciences, biotech, or medical device environments.

• Strong analytical thinking and clear, concise technical documentation.

• Demonstrated ability to collaborate effectively with suppliers and cross-functional engineering teams.

• Demonstrated ability to analyze data and propose fact-based, root-cause-driven improvements.

• Proven ability to manage tasks to completion within defined timelines while maintaining high documentation accuracy.

• Demonstrated ability to build strong working relationships with manufacturing and service teams and respond effectively to technical escalations.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.