Planet Pharma
From Planet Pharma's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
Job Summary
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, SolidWorks, 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.
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