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Sr Mechanical Design Engineer

Miami Lakes, FL 33014

Posted: 05/22/2023 Employment Type: Contract Job Category: Engineering Job Number: 566395 Is job remote?: No Country: United States

Job Description


I'm looking for a well-experienced Mechanical Design Engineer, with knowledge of electronics packaging for external battery-powered implantable devices using microprocessor control. Should have experience with micro-processor controller enclosures, external batteries enclosures, AC & DC Adapters and Cables for powering peripheral devices. Experience working with electronic devices Contract Manufacturers is necessary. Experience with FDA 21 CFR 820 Design Controls is necessary.

Education Required
• BS degree in Mechanical Engineering or MS preferred in Mechanical or Biomedical Engineering

Years of Experience
• 10+ years of product development with 4+ years product development of medical devices, class III preferred.
• Must have demonstrated completion of development projects to commercialization

Specialized Knowledge or Skills Required
• Ability to meet program deliverables and timing, and thrive in fast-paced environment.
• High organizational and multitasking abilities.
• Excellent verbal and written communication.
• Advanced understanding of design controls, quality system regulations, and failure investigation process and methodologies.
• PC application skills: solid modeling (SolidWorks), MS Project, EXCEL, Word, Minitab, Agile PLM
• Advanced understanding and application of GD&T (Geometric Dimensioning and Tolerancing).
• Understanding of international medical device standards.
• Understanding of Risk Management Process.
• Advanced understanding of Design-for-Manufacturability (DFM) and Design-for-Assembly (DFA)
• Experience with test methods validations and statistics.

Job:
Designs components or portions of systems and modifies existing designs to develop or improve products and facilitate manufacturing and field service operations.
• Design, document, assemble and test precision prototype and production fixturing.
• Assist in the design and development, and perform sustaining engineering, of various mechanical and electromechanical components used in this company's products.
• Assist with bench testing of assemblies and parts to ensure performance
• Maintain top level engineering documentation.
• Perform Design Validation testing
• Writing Protocols & Reports

Utilizes computer-aided design equipment and/or graphic tools, such as CAD, CAM, CATIA, ProEngineer/Creo, Solidworks or Siemens NX Software.
SolidWorks SME proficiency required.

Gathers information, makes studies, computes calculations, and prepares original rough layouts, sketches to present design proposal.
Coordinates design criteria with manufacturing, tooling, material, and planning groups such as ease of manufacture, availability of materials, and contractual specifications.
TECHNICAL SKILLS
Must Have
  • 10+ years of product development with 4+ years product development of medical devices, class III preferred.
  • Advanced understanding and application of GD&T (Geometric Dimensioning and Tolerancing).
  • Advanced understanding of design controls, quality system regulations, and failure investigation process and methodologies.
  • BS degree in Mechanical Engineering or MS preferred in Mechanical or Biomedical Engineering
  • Excellent verbal and written communication
  • Must have demonstrated completion of development projects to commercialization
  • PC application skills: solid modeling (SolidWorks), MS Project, EXCEL, Word, Minitab, Agile PLM

Nice To Have
  • Advanced understanding of Design-for-Manufacturability (DFM) and Design-for-Assembly (DFA)
  • Experience with test methods validations and statistics.
  • Understanding of international medical device standards
  • Understanding of Risk Management Process.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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