Senior Mechanical Engineer — Supplier Relocation & Qualification

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

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