Product Development Engineer - Parsippany, United States - Onkos Surgical

Description

Job Summary

The Onkos Surgical product development engineer is responsible for the conception through production implementation of design and development of new products, product improvements and value engineering to existing product lines through the use of technology, engineering principles and customer input to achieve the project deliverables (ex. quality, cost, and delivery). In addition, the product development engineer supports FDA submission requirements, develops and implements testing procedures, supports and develops quality systems as they relate to R&D, conducts product remediation exercises, root cause and engineering analyses, and works with manufacturing on design for manufacturability, quality testing, and inspection.

Responsibilities

· Ensures work output is compliant with all current regulatory and quality standards.

· Works with multidisciplinary project teams to develop, implement, complete and facilitate the following for the launch of safe and effective products:

Product voice of customer initiatives

Design and development of working prototypes through manufacturing equivalent final products

Design for manufacturability

Internal / external communications with 3^rd party vendors

Performance analyses of prototypes and final products

Performs and applies essential engineering rigor to all development of products such as:

• Optimizing available CAD tools
• Materials performance, intended use, environment, cleanability, sterilization technique, etc.
• Machining and processing techniques
• Performance testing, risk analysis, etc.

Mechanical testing plans/protocols and final product testing

Product quality requirements

Design controls

FDA documentation and testing requirements,

Product instructions for use

Procedural protocol development

Other requirements as project needs dictate

· Prepare comprehensive project plans with technical objectives (timing, resource requirements, costs, etc.).

· Provide engineering support for non-development needs such as quality, regulatory, or marketing initiatives that require engineering support, analyses and quantitative assessment of market and products.

· Comply with Design Control and Stage Gate processes while designing prototypes and products.

· Assist manufacturing engineers in developing innovative manufacturing and processing techniques and/or seek out new technologies for materials and processing through 3^rd party relationships.

· Develop low cost bench top tests to quickly and cost effectively evaluate product opportunities.

· Completes all required training in timely fashion.

Requirements

· A minimum of three years of successful related product development accomplishments in the medical device field, preferably orthopedic medical device development.

· Minimum of BS degree in scientific discipline, preferably Mechanical or Biomedical Engineering.

· Ability to apply analytical skills, in solving engineering problems and developing new products, techniques or designs.

· High degree of demonstrated mastery with CAD systems (Solidworks, NX, Creo, etc.) to facilitate rapid deployment of new product development initiatives.

· Demonstrated computer skills including spreadsheets, word processing, database and other applicable software programs.

· Excellent interpersonal skills; self-motivated and flexible to changing schedules.

· Strong attention to detail, good oral and written communication skills.

· Experience working with surgeons on product design a strong plus.

· Travel requirement up to 5%.