Medical Device Systems Engineer V&V jobs in United States
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Ecocareers ยท 1 month ago

Medical Device Systems Engineer V&V

Confidential company is seeking a Senior Systems and V&V Engineer to join their R&D project team. The role involves providing technical contributions to system design and Verification/Validation of complex medical devices throughout the product life cycle.

Staffing & Recruiting

Responsibilities

Defines customer needs and creates/modifies system requirements and architecture to meet them
Evaluates constraints, makes trade-off decisions, and contributes to module-level design requirements
Participates in product safety and security risk management activities, including DFMEA
Identifies technical risks and mitigations
Develops and executes verification and validation plans, protocols, scripts, regression, and reports
Collaborates closely with the Lead Engineer, Project Manager, and cross-functional teams to ensure project success
Provides guidance in design reviews and helps resolve technical issues
Focus on Systems and V&V Engineering for sustaining legacy products and/or new product development
Deliver all system and/or V&V engineering outputs with high quality
Generate alternatives and take reasonable risks when solving technical problems
Complete detailed, high-quality technical documentation to capture and communicate designs
Stay informed on business, market, and competitive environments
Use existing tools and best practices to report and track product and process metrics
Communicate proactively about developments or issues affecting work and commitments
Perform other duties as assigned

Qualification

Medical device regulationsSystems engineering toolsVerificationValidationTechnical writingInterpersonal skillsAdaptabilityProblem-solvingCollaboration

Required

Bachelor's Degree in Engineering
3+ years of relevant experience
Ability to generate alternative solutions for technical problems or processes
Strong interpersonal skills; works collaboratively in a team environment
Adaptable to change and demonstrates good judgment in selecting methods and techniques
Proficient with systems engineering tools such as DOORS, Polarion, and Minitab
Familiarity with multiple systems areas: electrical, mechanical, pneumatic, software, materials, and/or wireless connectivity
Strong technical writing and communication skills

Preferred

Knowledge of medical device regulations and standards, including design control and risk management

Company

Ecocareers

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Funding

Current Stage
Early Stage
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