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Senior Product Development Engineer - 1691314
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Senior Product Development Engineer

Develop products for an organization known as the international standard for voice restoration. You will help thousands of patients worldwide regain their ability to speak. Know that in this position you will be improving the lives of entire families by allowing them to hear the stories of the people closest to them, and allowing them to live more easily in the world.

Onsite or Hybrid (minimum 4 days per week in the Carpinteria, CA office, contingent on business need with 1 day per week working from a home office).

What you’ll be doing:

  • Leading functional teams or projects with substantial resource requirements, risk, complexity and strategic importance for the organization.
  • Working closely with internal and external stakeholders to ensure scope, expectations, and product/design requirements are fully understood.
  • Tracking and monitoring budgets, timelines, and performance indicators.
  • Interacting with patients or physicians and applying empathy to identify unmet clinical needs.
  • Conducting and or participating in brainstorming sessions to identify creative ideas and unique solutions.
  • Creating and prototyping concepts through the use of 3D CAD software and rapid prototyping methodologies, along with creating specifications for device components, assemblies, packaging and labeling.
  • Working with Manufacturing, external suppliers and other Product Development engineers to ensure that products are optimally designed for manufacturing. 
  • Defining and implementing the equipment needed to support manufacturing, 
  • Developing and validating relevant processes and ensuring sites are prepared for new product launches.
  • Preparing for and conducting risk management activities and various design reviews in accordance with regulatory requirements.
  • Verifying that designs meet functional requirements through the performance of engineering analyses and testing.
  • Validating designs against user needs through clinical evaluations, usability engineering and or analysis, in collaboration with the clinical research team.
  • Supporting the development of test and inspection plans and ensuring quality requirements are met and manufacturing process risks are mitigated.
  • Utilizing common laboratory test equipment and performing hands-on mechanical and electrical testing.
  • Specifying fixtures, gauges, and equipment needed for the verification and manufacture of devices.
  • Providing technical support to manufacturing engineering for design and process improvements made post transfer (i.e. sustaining engineering).
  • Participating in regulatory audits & compliance activities for aspects related to Design & Development.
  • Providing coaching, and guidance regarding project tasks to other engineers, designers, technicians and associates while promoting employee development and fostering growth of employees through effective mentoring.

What you’ll need

  • Bachelor of Science engineering degree, BSME or BSBME (or related discipline) 
  • Minimum 5 to 8+ years’ experience in product development for a medical device company.
  • Thorough understanding of Design Controls (21CFR Part 820.30, ISO 13485), Risk Management (ISO 14971) and Biocompatibility (ISO 10993).
  • Working knowledge of manufacturing processes (e.g. molding, extrusion, machining, assembly).
  • Strong mechanical, analytical & problem-solving skills.
  • Strong technical writing ability.
  • Leadership ability and organizational skills.
  • Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
  • Proficiency in the use of PC and programs, particularly SolidWorks, Project, Excel, Word, PowerPoint.
  • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and associates.
  • Execute tasks in a timely manner without direct supervision.
  • Ability to prioritize tasks.

Preferred Qualifications

  • Advanced engineering degree
  • Previous experience with Ear, Nose & Throat (ENT) medical products.
  • Project management training and or certifications.

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