Katalyst CRO · 6 days ago
Mechanical Engineer
St Paul, MN
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is seeking a highly skilled and motivated Mechanical Engineer to join their Urology Research & Development organization for a six-month project. The role involves integrating the acquired company’s Design History File to compliance and assessing design verification and test methods to determine the need for additional testing.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Hiring Manager
Mounika Guttula
Responsibilities
Identifying gaps in the acquired company’s DHF compliance to Work Instructions and SOPs and contributing to strategy to close these gaps
Providing input to project goals and progress and recommending appropriate revisions
Communicating progress, risks, and trade-offs of technical deliverables to project leadership and recommending revisions as needed
Completing complex or novel assignments requiring the development of new or improved techniques and procedures. Work is expected to result in efficient and effective integration of medical device technologies to the portfolio
Successfully completing engineering work in one or more of the following: Design FMEA; Design Verification test method; test method validation; DV protocol, testing, and report; Essential Design Output identification; and requirements tracing, skills
Qualification
Required
BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
2+ years of Medical device experience (Class II/III)
Strong mechanical and/or systems engineering
Test Method Development (TMV)
Design verification, test methods, and design outputs
Design History File (DHF)
Experience with statistical techniques (Gauge R&R, Process Capabilities Studies) and Minitab
Strong problem-solving skills and attention to detail
Preferred
Familiarity with IEC 14708 and 45502 Active Implantable standards
Familiarity with IEC 60601 Medical Electrical Equipment standards, including laser-specific sections
Experience with Windchill
Experience in single-use device or active implantable test methods and test method validation
Ability to build strong relationships across the organization and with external stakeholders
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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