Product Development Engineer - Vancouver
12 hours ago

Job description
KEY RESPONSIBILITIES:
Product Development & NPI Leadership
Lead, Conduct, and Perform product development activities, including design, validation, regulatory compliance, and manufacturing readiness.
Prominent player in NPI roadmap, including support in development of schedules, milestones, design freezes, pilot builds, and production handoff, ensuring all activities are executed efficiently and in compliance with internal quality system procedures, industry standards, and regulatory requirements.
Assess and convert customer, marketing, and regulatory requirements into formal design inputsWork closely with customer-facing teams to transform user feedback into product characteristic and technical requirements inputs
Work closely with internal and external product development experts and suppliers to develop and improve product design
Initiate, complete and maintain Engineering Change Orders for mechanical engineering projects
Mechanical/Sustaining Engineering Leadership
Serve as the technical authority for mechanical design as required.
Define and enforce mechanical design standards, drawing practices, and CAD requirements
Participate and contribute to Process Validation or alternative statistical process control (SPC) methodology or tools wherever applicable
Review and approve DFMEA, tolerance stacks, reliability models, and design reviews
Resolve complex, design, tooling, or manufacturability challenges
Perform product failure investigations and other CAPA related activities
Provide the Engineering team with technical support and training as necessary
Collaborate with Quality, Regulatory, and Operations teams to ensure continuous compliance and product reliability
Contribute to the refinement of product design to improve efficiency and scalability
Regulatory & Compliance Ownership
Serve as technical owner for product compliance and certification.
Identify applicable global standards (UL, CSA, CE, UKCA, FCC, IEC, ISO, RoHS, REACH, etc.)
Lead compliance planning from early design, ensuring requirements is embedded in product architecture.
Manage third-party testing labs and certification bodies
Support regulatory audits, factory inspections, and compliance reviews
EDUCATION AND EXPERIENCE:
Bachelor's degree in system engineering or equivalent experience
5-8 years of experience in product engineering for marketed products, spanning the full product life cycle: R&D, NPI, and sustaining engineering
Proven experience taking multiple products from concept to mass production
Strong background in regulatory compliance and certification for consumer, industrial, or electronic products
Experience working in a ISO9001/ISO 13485 and cGMP environment, design documentation, risk management, verification and validation
Must have experience in the medical device industry
Deep knowledge of mechanical design, materials, tolerancing, GD&T
Proficient in CAD (Solidworks, AutoCAD, or equivalent) and PDM systems
Experience performing risk management, reliability engineering, DFMEA, PFMEA, and etc.
Demonstrated leadership ability
Proficient planning, scheduling, and organizing skills
Strong troubleshooting and problem-solving skills including root-cause analysis (5 Whys, Fishbone, etc)
Excellent English verbal and written communication skills
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