Senior Product Development Engineer

Senior Product Development Engineer Acuitive Technologies Inc. Allendale, NJ Job Details Permanent | Full-time $115,000 - $150,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Qualifications Developing medical devices 3D CAD modeling Engineering testing Interpersonal skills Bachelor's degree in engineering Bachelor's degree Team management Medical device design Experimental design Adaptability Design controls Quality systems Analytical thinking Project leadership Research & development Technical Proficiency

ISO 13485

Cross-functional communication FDA regulations Statistical analysis tools Mechanical product development projects Full Job Description Job Summary This individual will be the first level of project management and lead the design, development and testing of system implants and instruments. Responsible for all products and supporting design control documentation intended for commercial release in a regulated medical device market both FDA and EU regulations. This position works closely with the manufacturing operations, quality assurance and marketing/sales functions and may also collaborate on projects with outside strategic partners. General Functions Leads the development of new products and manufacturing processes or serves as a key member on a project team Directs the generation of prototype models to evaluate new design concepts Develops technical solutions to complex problems using sound engineering principles and design of experiments (DOE) while utilizing experimental, computational, and/or analytical methods. Generates a comprehensive protocol for testing/analyzing the product Develops robust test methods, design test fixtures including tolerance stack-up and execute measurement system analysis. Plan and performs hands on bench-top studies, design verification, troubleshooting and/or root-cause-analysis in order to evaluate product performance & improvements Performs data analysis using statistical tools, generate reports and present recommendations to peers and business leaders. Supports material, design and/or process changes to existing products by for flowing design control process and generating well-documented research and analyses records. Generates design control documentation for the project Demonstrate strong drive for results and clear accountability for successful and timely completion of designated tasks and projects. Oversee technical teams to ensure project plans adhere to agreed upon timelines and are within the scope of the Project and Quality System Mentor other engineers in product development and project management best practices and industry trends Manage team resources planning and allocation Work Experience Requirements 5+ years' experience in medical device research and development environment, preferably with small to mid-size companies or in developing functions within larger companies Hands-on design and development of orthopedic implants and instruments Engineering software knowledge and user capability, Proficiency in solid CAD modeling (SolidWorks or equivalent) Must be results oriented, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines Proficiency with statistical methods including DoE and data analysis using software such as Minitab Experience in test method development (fixture design and hands-on testing) Proficiency with any of FEA and/or CFD modeling software is a plus Strong hands-on and craftsmanship skills are strongly desirable for this position Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams Skill Requirements Critical reasoning and analytical skills Excellent communication, both oral and written, and interpersonal skills necessary to interact with wide range of individuals Strong interpersonal skills including tact, diplomacy, ability to negotiate and ability to express opinion in a dynamic and strong-willed start-up environment Flexibility and ability to adapt to change Education Requirements Minimum Bachelor's Degree in engineering Medical device, QMSR, and ISO training 5+ years management experience in medical device engineering and research No recruiters/agencies. Principals only.

Pay:

$115,000.00 - $150,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off

Work Location:

In person