Katalyst CRO · 1 day ago
Sr Mechanical Engineer
United States
Contract
Remote
Mid, Senior Level
3+ years expKatalyst Healthcares & Life Sciences is seeking a highly skilled and motivated Mechanical Engineer to join their Urology Research & Development organization for a project duration of ten months. The role involves providing support in integrating the acquired company's Design History File to compliance, specifically for a nerve stimulation product, and includes responsibilities such as gap assessment, engineering documentation, and test method validation.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Identifying gaps in the acquired company's DHF to Work Instructions and SOPs and contributing to strategy to close these gaps, specifically on a trial nerve stimulator device for overactive bladder
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
Successfully completing engineering work in one or more of the following: Device Requirements Design FMEA; Design Verification test method; test method validation; DV protocol, testing, and report; Essential Design Output identification; and requirements tracing
Completing clear and concise engineering documentation, including protocols, reports, and rationales
Demonstrating Technology Development and Product Development system knowledge through delivery of high quality, high impact deliverables
Taking DHF data from newly acquired company and convert it to clients compliance
Defining design or test requirements, run new DHF testing of commercially utilized product
This is not new product development (NPD), this product is already on the market
Pulse generators (lower back implants for overactive bladder)
Assessing existing DHF, gap assessment, look through DFMEA and design requirements, Test methods
Six Sigma - Problem solving
Qualification
Required
BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
3+ years of medical device engineering experience
Strong mechanical and/or systems engineering and problem-solving skills and attention to detail
Gauge R&R and Minitab
Test Method Validation
DHF, DFMEA
Experience with change management and issue tracking tools such as JIRA, AccuRev, Windchill etc
10% travel to California site (Irvine, CA) - twice during assignment
Preferred
Familiarity with IEC 14708 and 45502 Active Implantable standards
Familiarity with IEC 60601 Medical Electrical Equipment standards, including laser-specific sections
DMAIC problem-solving skills
Experience with statistical techniques (Gauge R&R, Process Capabilities Studies) and Minitab
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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