Medical Device Systems Engineer V&V Job at Katalyst HealthCares and Life Sciences, Batesville, IN

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  • Katalyst HealthCares and Life Sciences
  • Batesville, IN

Job Description

Summary:

As part of an R&D project team, the Senior Systems and V&V Engineer provides technical contributions to system design and Verification/Validation of complex medical devices from concept through commercialization, or across the full product life cycle.
Roles & 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.

Education & Experience
  • 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.
  • Knowledge of medical device regulations and standards, including design control and risk management (preferred).
  • 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.

Job Tags

Full time,

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