Sr Mechanical Engineer

Planet Pharma; Hayward (CA); Hybrid; USD 75,000 - 94,000; Full time

Job summary

Planet Pharma is seeking a Senior Mechanical Engineer to lead the technical qualification of supplier relocations for DNA sequencing systems. You will assess, document, and validate mechanical and system-level changes, coordinating with suppliers and internal teams to ensure continued design, quality, reliability, and performance.

You will review drawings, BOMs, and processes; define qualification requirements; run risk assessments; and drive issue resolution with root-cause analysis and

Qualifications

• MS in Mechanical Engineering with 5+ years of relevant experience.
• BS in Mechanical Engineering with 8+ years of relevant experience.
• Experience in sustaining engineering, supplier quality, part qualification, or manufacturing transfer in regulated environments.

Responsibilities

• 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 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 for part qualification.
• Lead resolution of qualification failures, supplier deviations, and technical issues through root‑cause analysis and corrective actions.
• Partner with Quality, Manufacturing, Supply Chain, Regulatory, Process Engineering, and other teams to review qualification evidence and obtain internal approvals.
• Drive supplier-relocation changes through documentation updates, change control, part and supplier approvals, lifecycle-management review, and release to manufacturing.
• Maintain complete qualification records and deliver projects within committed timelines and budgets, communicating risks and recovery plans.

Skills

SolidWorks

GD&T

Mechanical design

Supplier qualification

Root-cause analysis

Cross-functional comms

Written/verbal communication

Education

MS in Mechanical Engineering

BS in Mechanical Engineering

Tools

SolidWorks

Job description

Pay54.50-68.28/h depending on experience

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.

Key Responsibilities

• 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.

Requirements

• 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.