Sr Mechanical Engineer

The Senior Mechanical Engineer will lead the technical qualification of supplier relocations for DNA sequencing systems. This position is responsible for ensuring that all mechanical and system-level technical considerations associated with a supplier relocation are thoroughly assessed, documented, and validated. The engineer will collaborate with suppliers and cross-functional teams to identify risks, define qualification requirements, execute verification and validation activities, and confirm that relocated manufacturing processes and components continue to meet design, quality, reliability, and performance requirements.

• Lead supplier-relocation engineering activities and develop qualification strategies, scope, requirements, schedules, budgets, risks, and deliverables for mechanical parts, assemblies, and manufacturing processes.
• Review drawings, specifications, BOMs, manufacturing processes, tooling, inspection methods, and historical quality data to identify technical gaps and define qualification requirements.
• Collaborate with suppliers to obtain required documentation, qualification samples, inspection records, material certifications, capability studies, and validation evidence.
• Develop and execute risk assessments, verification and validation protocols, dimensional and functional testing, measurement-system analysis, and process‑capability studies needed for part qualification.
• Lead resolution of qualification failures, supplier deviations, and technical issues through root‑cause analysis, corrective action, and documented retesting.
• Partner with Quality, Manufacturing, Supply Chain, Regulatory, Process Engineering, and other teams to review qualification evidence and obtain required internal approvals.
• Drive supplier‑relocation changes through company processes, including documentation updates, change control, part and supplier approval, lifecycle‑management review, and release to manufacturing.
• Maintain complete qualification records and deliver projects within committed timelines and budgets, proactively communicating risks and implementing recovery plans when needed.

• M.S. in Mechanical Engineering with 5+ years of relevant experience, or B.S. in Mechanical Engineering with 8+ years of relevant experience.
• Experience in sustaining engineering, supplier quality, part qualification, or manufacturing transfer, preferably in life sciences, medical devices, or another regulated industry.
• Strong proficiency in mechanical design, Solid Works, GD&T, precision assemblies, materials, manufacturing processes, and supplier part qualification.
• Ability to connect material properties, dimensional variation, process capability, and fabrication methods to product performance and qualification requirements.
• Demonstrated ability to lead root‑cause analysis, resolve supplier technical issues, and implement effective corrective actions.
• Excellent verbal, written, and technical communication skills, with the ability to align suppliers and cross‑functional teams on requirements, risks, evidence, decisions, and approval timelines.
• Ability to prepare clear engineering documentation, present complex qualification evidence, and independently manage multiple supplier‑relocation priorities.
• Experience with FDA‑regulated products is a plus.
• Previous should‑cost analysis experience is a plus.