Director – Design Quality Engineering – Ultrasound
Philips
full-time
Posted on:
Location Type: Office
Location: Bothell • California, Massachusetts, Minnesota, Pennsylvania, Tennessee, Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $153,750 - $275,520 per year
Job Level
Lead
About the role
- Lead and develop a global Design Quality Engineering team
- Support the development and introduction of new Ultrasound products and sustaining releases
- Ensure Ultrasound products/offerings are developed in accordance with Philips’ design control requirements and applicable standards/regulations
- Drive a culture of quality and first time right to meet safety, reliability and efficacy requirements
- Partner with R&D, Product Management, Medical Safety & Clinical and other key functions
Requirements
- 10+ years’ experience in Design Quality Engineering/Risk management for FDA regulated Medical Device (21 CFR 820, ISO 13485/14971)
- 5+ years’ experience in Functional/Strategic leadership of Design Quality Engineering teams
- Extensive experience engaging with FDA investigators, other external regulators/auditors during inspections/audits
- Proven expertise in translating complex designs/principles/technical documents into audit/regulatory ready design documents/records
- Highly skilled in statistical techniques, including design of experiments (DOE) and sampling plans
- Minimum of a Bachelor’s Degree (Required) in Engineering, Quality, Regulatory or comparable disciplines.
Benefits
- PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Design Quality EngineeringRisk managementStatistical techniquesDesign of experiments (DOE)Sampling plansRegulatory complianceAudit preparationTechnical documentationFDA regulationsISO 13485
Soft skills
LeadershipCollaborationCommunicationProblem-solvingQuality assurance culture
Certifications
Bachelor's Degree in EngineeringBachelor's Degree in QualityBachelor's Degree in Regulatory