Product Development Engineer

Product Development Engineer

Summary

The Product Development Engineer works within the engineering department to develop new medical device products, communicate directly with customers to understand product requirements and usability, investigate and respond to customer complaints on existing product lines, provides technical support to sales reps and customers, and provide risk analysis on products. Work will center on cryopreservation and cell culture disposable products.

Product Development Engineer Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Engineering activities include:

  • Accompany sales reps on site visits to customers to evaluate the end use of existing products to help maintain current usability flow charts.

  • Understand all technical aspects of existing products and how they relate to customer needs.

  • Provide technical support and creative problem solving to sales reps, distributors, and directly to customers.

  • Evaluate and provide engineering analysis in collaboration with the marketing analysis of development opportunities in the cryopreservation and cell culture spaces.

  • Use knowledge of company capabilities and customer needs to provide innovative product ideas.

  • Oversee custom product development within existing product lines; includes cost of goods estimation, preparation of drawings, release of documentation, and transfer to production.

  • Develop new product lines within cryopreservation and cell culture from inception to production transfer; includes creation of Design History Files, design verification and validation protocols and reports.

  • Investigate customer complaints to determine root cause of failure, write report summary to customer, assist with implementation of solutions, and report trends as necessary.

  • Write or revise technical documentation for new and existing products, such as Instructions for Use, Advisory Notices, and Technical Bulletins to be provided to customers.

  • Provide a user context for internal analysis of risk for complaints, CAPAs, material non-conformances, and other quality systems.

Competencies

  • Knowledge of regulations and guidelines for medical device development.

  • Established skills in direct customer interaction.

  • Proficiency in technical writing and professional correspondence with customers.

  • Ability to work both independently and in cross functional groups.

  • Outstanding communication skills, both written and oral, and will be expected to communicate directly with customers, sales reps, distributors, engineers, marketing, and senior management. 

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, printers, etc.
  • This job periodically operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided items such as; cleanroom coat, bouffant, face mask, and gloves.
  • Working from home or remotely is occasionally available, typically 2 -3 days per month.

Physical Demands

  • Position may require frequent communication and walking to other areas in which designated personal protective equipment will be required.
  • Majority of time will be spent manipulating data at computer, sitting, reaching, bending, and twisting.
  • Employee may occasionally lift and/or move up to 20 pounds.
  • This position has been approved for relocation assistance.

 

Position Type and Expected Hours of Work

This is a full-time position.

Days and hours of work are typically Monday through Friday, 8:00 a.m. to 5 p.m. In some cases, additional work hours may be required.

Travel

15%

Education and Experience

  • Bachelor’s Degree in Engineering

    • Preferred: chemical, biomedical, or mechanical preferred

  • 3+ years’ experience in an engineering position in life sciences industry

    • Preferred: medical device

Salary:

Commensurate with Experience 

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail. Click here  for our contact information.