Product Development Engineer

Onkos Surgical•Parsippany, NJ

61d

About The Position

The Development Engineer leads or participates on teams responsible for the design and development of surgical implants and instruments from concept through launch. The focus of these development projects has a heavy emphasis on the individualized treatment of patients on behalf of a requesting surgeon. The role also encompasses implementation of improvements and value engineering to existing patient specific product offerings and services, support of the development of the quality system and other company initiatives.

Requirements

Passion to find solutions to our patients' unmet clinical needs and to advocate for their cause.
Bachelor's degree in engineering or life sciences discipline. Mechanical or Biomedical Engineering preferred.
3+ years of product development experience in the medical device field, preferably related to orthopedics. Experience working with surgeons on product design a strong plus.
Ability to apply engineering principles to solve problems and develop new products and techniques.
Demonstrated ability with CAD software. SOLIDWORKS and NX preferred.
Must be self-motivated, able to work independently, and thrive in a fast-paced dynamic environment.
Strong attention to detail, interpersonal skills, and oral and written communication skills.
Must be willing to attend and participate in cadaveric product evaluations and attend surgery for observation and/or technical support.
Travel: Up to 5%

Responsibilities

Adhere to Onkos Core Beliefs, Code of Business Conduct, all regulatory requirements and quality standards.
Support company advocacy initiatives to help raise awareness of sarcoma and pediatric cancer and drive positive change that will impact the lives of cancer patients.
Prepare and manage to comprehensive project plans, resource requirements, project budgets, timelines, etc.
Interface with sales force, surgeons, and other stakeholders to understand customer needs in order to define design inputs, draft product performance requirements, and draft surgical techniques.
Utilize CAD software to model designs and detail engineering drawings, optimizing designs for quality, manufacturability, inspectability, and cost.
Facilitate manufacture of prototypes and test articles.
Develop and execute product test plans ranging from early bench testing/prototype evaluation to final validation and verification.
Partner with regulatory team to fulfill all requirements for regulatory submissions and reports.
Generate design controls, risk management documentation, and other technical memos, conducting root cause and engineering analyses as necessary.
Support quality, regulatory, and marketing initiatives that require engineering assistance, analyses and quantitative assessments of markets and products.
Assist in developing innovative manufacturing and processing techniques and/or seek out new technologies for materials and processing through 3rd party relationships.
Consult with surgeons and sales force to identify potential solutions for difficult patient cases.