Senior Product Development Engineer

4 weeks ago

Parsippany, United States ONKOS SURGICAL Full time

The Onkos Surgical Senior Product Development Engineer leads or participates on teams responsible for all phases of the design, development, and regulatory clearance of antibacterial coatings on surgical implants.

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.
  • Lead the product testing needed for regulatory clearance of anti-bacterial coated implants.
  • Prepare and manage 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.
  • Participate in coating process development, optimizing the process 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 as required by the Onkos Quality System and regulatory submissions
  • Partner with regulatory team to fulfill all requirements for regulatory submissions and reports.
  • Partner with outside development partner and testing vendors to establish and execute development and testing timelines.
  • 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.

Requirements

  • Passion to find solutions to our patients unmet clinical needs and to advocate for their cause.
  • Bachelors degree in engineering or life sciences discipline. Biomedical or Materials Engineering preferred.
  • 5+ years of product development experience in the medical device field, preferably related to orthopaedic or other medical device coatings. Experience in securing FDA regulatory clearances a strong plus.
  • Ability to apply engineering principles to solve problems and develop new products and techniques.
  • Demonstrated ability with statistics and related product performance analysis.
  • Knowledge of CAD software. SOLIDWORKS 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.
  • Travel requirement: Up to 20%.

About Onkos

At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause.

At Onkos Surgical, we exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients.

At Onkos Surgical, we will:

  • Find solutions to our patients unmet clinical needs and advocate for their cause.
  • Partner with surgical oncologists through research, education, and innovation, to treat their patients more effectively and more efficiently.
  • Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.
  • Fulfill our employees desire to make a difference in the lives of the patients they serve while achieving their own professional growth.
  • Deliver value to our customers and shareholders.

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