{"id":3853502,"url":"https://alion.io/job/planet-pharma-design-quality-engineer","title":"Design Quality Engineer","company":{"id":4467183,"name":"Planet Pharma","domain":"planet-pharma.com","url":"https://alion.io/company/planet-pharma","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":{"grade":"B","score":80,"open_postings":11,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":15,"computed_at":"2026-11-09T06:03:00Z"}},"role":"MedTech","role_family":"MedTech","seniority":"senior","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Northridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"EU MDR","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Minitab","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-07-14T00:00:00Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-10T01:49:07Z","board_verified":true,"closed_at":null,"days_open":119,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":118},"description":"Pay 50-60/h depending on experience\n“Design Quality Engineer - Process Development to support new product introduction (NPI) and production scale-up activities within the diabetes medical device space. This individual will drive process validation strategies, lead process risk management (PFMEA), and serve as a critical crossfunctional liaison between internal Supplier Quality, R&D, Contract Manufacturers, and NPI teams. The ideal candidate brings deep expertise in process development, FMEA methodologies, and regulatory compliance -A proven track record of resolving critical production issues during scale-up and mentoring engineering teams is essential.\nProcess Development & Validation\n* Develop P-diagrams, Input-Process-Output (IPO) matrices, process characterizations, and test method validation (TMV) strategies for NPI programs.\n* Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up.\n* Apply methodologies including Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA),\nand Cell Operating System (COS).\n* Drive risk mitigation approaches by integrating qualification parts early in process development phases\nProcess Risk Management & Risk Navigation\n* Facilitate and generate Process Failure Modes Effects Analysis (PFMEA) documents for manufacturing processes during NPI and scale-up.\n* Maintain strong working knowledge of design risk documentation (RAD, DFMEA, HRA) to critically analyze process-related failures and identify gaps.\n* Recognize when process findings have design risk implications and escalate appropriately to Design Quality Assurance (DQA) partners for design risk\nassessment decisions.\n* Leverage understanding of risk documentation during root cause investigations and critical analyses to ensure comprehensive disposition.\n* Conduct thorough root cause investigations using A3 Problem Solving methodology, fishbone diagrams, 5-Why analysis, and brainstorming techniques\nCross-Functional Engagement & Collaboration\n* Serve as the primary quality interface between internal Supplier Quality Engineering (SQE), R&D cross-functional teams, Contract Manufacturers, and NPI\nprogram teams\n* Facilitate regular cadence of alignment discussions with Supplier Quality and vendors to implement updated control plans, inspection criteria, and risk\ndocumentation.\n* Collaborate with R&D teams to translate design intent into manufacturable process parameters during design transfer\n* Partner with NPI groups to ensure seamless transition from development builds through production qualification and commercial readiness.\n* Ensure alignment between contract manufacturers and internal teams on deliverables, expectations, and quality standards.\n* Bridge QMS gaps between contract manufacturing partners and internal quality systems, standardizing documentation templates and expectations.\n* Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections.\nProduction Scale-Up Support & Crisis Management\n* Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization.\n* Conduct root cause investigations (A3 methodology) and implement Corrective and Preventive Actions (CAPA).\n* Strategize and guide engineering teams to deploy effective investigation approaches for supplier and manufacturing issues.\n* Proactively identify production risks during scale-up and drive containment/resolution before they impact launch timelines.\nStatistical Analysis & Data-Driven Decision Making\n* Perform statistical analyses including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, and GR&R using Minitab.\n* Utilize statistical process control (SPC), I-MR charts, Box plots, and Normality & No”\nRequired Skills & Qualifications\n* Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field AND 5+ years of experience in process development, manufacturing, or quality engineering for medical devices\nOR\n* Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related engineering field AND 7+ years of experience in process development,\nmanufacturing, or quality engineering for medical devices”\n* 4+ years applying DRM, DFSS, DFMA, and COS methodologies in medical device process development\n* 4+ years facilitating and generating PFMEA documents; strong working knowledge of DFMEA and design risk documentation (RAD, HRA) sufficient to identify\ngaps and escalate appropriately\n* 4+ years developing process parameters, DOEs, P-diagrams/IPO matrices, process characterizations, and process validation strategies (IQ/OQ/PQ/TMV)\n* 4+ years performing statistical analysis (hypothesis testing, confidence/tolerance intervals, regression, capability analysis, DOEs, GR&R) in Minitab\n* 4+ years working within FDA QSR, ISO 13485, ISO 14971, ISO 11135, ISO 11737, and EU MDR regulatory frameworks\n* 4+ years coordinating Design Control, Design Verification, Process Validation, root cause investigations, and CAPA activities\n* Demonstrated experience collaborating cross-functionally with Supplier Quality, R&D, Contract Manufacturers, and NPI teams in a matrixed environment\n* Demonstrated experience utilizing Good Manufacturing Practices (GMP) and FMECA\nPreferred Qualifications\n* Experience with CGM (Continuous Glucose Monitoring) sensors or insulin pump systems\n* Proven track record resolving production holds during NPI commercialization and scale-up\n* Experience managing design transfer and production scale-up activities with contract manufacturers.\n* Experience serving as the quality “”bridge”” between multiple external partners and internal stakeholders\n* Experience with problem-solving methodology\n* CQE (Certified Quality Engineer) or Six Sigma Black Belt certification\n* Familiarity with automated manufacturing lines and assembly-level process 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