Engineer

 

GENERAL DUTIES AND RESPONSIBILITIES:

  • Support design, development, and manufacturing of temporary pacing leads from concept design through commercialization.

  • Optimize the product design and improve manufacturing processes to resolve issues in manufacturing, improve product performance, and lower cost of goods.

  • Support expansion of manufacturing operations through installation of expanded cleanroom facility requiring hands on support to establish equipment, tooling, product flow, training, and inspection requirements.

  • Assess and implement opportunities to manufacture subassemblies and finished devices through contract manufacturers and support transition of manufacturing operations as needed.

  • Lead efforts in developing and executing product verification and validation testing as well as process validation activities consistent with design changes, product requirements, risk assessments, and other product descriptive documents.

  • Develop and implement manufacturing processes, technologies, and tooling needed to achieve a lean production model.

  • Support inspection, packaging, labelling and sterilization for commercial product.

  • Collaborate with Operations, Regulatory, Marketing and Quality departments on product complaint investigations.

  • Contribute to the intellectual property position of the company via invention and patent applications.

  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA and ISO regulations.

  • Comfortable working independently in an early-stage development and manufacturing organization managing multiple priorities.


EXPERIENCE/EDUCATION REQUIREMENTS:   

  • Bachelor's degree in engineering from an accredited four-year college or university.

  • 10 or more years in medical catheter or implantable device R&D or manufacturing experience.  AIMD experience a plus.

  • Ability to interpret and analyze statistical data, understand and resolve technical difficulties, and interface with internal and vendor engineering/technical experts.

  • Strong understanding of FDA and ISO medical device manufacturing requirements required.

  • Engineering drawing proficiency with Solidworks and PDM required.

  • Experience writing protocols, test plans, test reports and design control deliverables 

  • Experience with standard laboratory test equipment.

  • General computer skills (Microsoft Office, Project, PowerPoint, Excel, Minitab).