Katalyst CRO ยท 1 month ago
Medical Device Systems Engineer V&V
Batesville, IN
Contract
Onsite
Mid Level
3+ years expKatalyst Healthcares & Life Sciences is seeking a Senior Systems and V&V Engineer to provide technical contributions to system design and Verification/Validation of complex medical devices. This role involves defining customer needs, developing verification and validation plans, and collaborating with cross-functional teams to ensure project success.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
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
Strong technical writing and communication skills
Preferred
Knowledge of medical device regulations and standards, including design control and risk management
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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