Senior Mechanical Product Engineer
hace 2 meses
Key Responsibilities:
- Develop and validate design inputs based on user requirements, formulate testing protocols, and execute comprehensive testing procedures.
- Engineer and innovate mechanical systems and components tailored for medical technology.
- Perform feasibility assessments and deliver technical guidance for both new and existing product lines.
- Generate and uphold 3D models, assemblies, and engineering documentation in accordance with ASME Y14.5 standards.
- Ensure adherence to pertinent regulatory and industry standards for product compliance.
- Collaborate effectively with multidisciplinary teams, including operations, supply chain, regulatory affairs, and quality assurance, to guarantee timely project execution.
- Oversee the complete change control process from initiation through to production.
- Engage in design evaluations and offer constructive insights to enhance product designs.
Required Experience:
- At least 4 years of experience in research and development or sustaining engineering within the medical device sector.
Educational Background:
- Bachelor’s degree or higher in Mechanical Engineering or a related discipline.
Skills and Competencies:
- In-depth understanding of Mechanical Engineering principles, including mechanics and materials science.
- Proficient in Solidworks, including 3D modeling, assemblies, and engineering drawings compliant with ASME Y14 series.
- Familiarity with product development methodologies, encompassing design controls, risk management, and verification and validation processes.
- Experience in medical device development and knowledge of relevant regulatory compliance such as IEC 62304 and medical device design controls (21 CFR Part 820).
- Strong analytical and problem-solving capabilities.
- Excellent communication skills in English, both written and verbal, with the ability to produce reports, protocols, procedures, presentations, and other documentation. Capable of effectively conveying information to peers and management.
- Ability to thrive in a dynamic, high-pressure environment while meeting project deadlines.
Work Environment:
- Hybrid work model available, requiring a minimum of 2 days in the office, or as dictated by business needs.
- Primarily office-based work supplemented by hands-on activities in the engineering lab for prototype development and troubleshooting of electronic or mechatronic devices.
Travel Requirements:
- Occasional travel may be necessary, up to 10% of the time.
CooperCompanies is dedicated to fostering a robust quality management system and ensuring its effectiveness by emphasizing the importance of meeting customer and regulatory requirements.
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