Senior Mechanical Product Engineer

hace 2 meses


Alajuela, Alajuela, Costa Rica CooperCompanies A tiempo completo

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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