Our Mequon area Client has an immediate need for a Product Development Engineer for a "Direct Hire" position.
The Product Development Engineer is responsible for the day-to-day design and development of new and improved product (spinal implant and instrument) using the company’s design control procedure and in compliance to the quality management system. The Product Development Engineer is responsible to execute the design and development activities throughout the product development lifecycle, from cradle-to-grave. Must possess and apply knowledge of medical device engineering principles, practices, and procedures. The Product Development Engineer is also responsible for maintaining compliance to industry guidelines and regulatory requirements, and maintaining Design History Files for new and legacy products.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
QUALIFICATIONS AND REQUIREMENTS:
- Responsible for activities associated with the design and development of new product, specialty product, and sustaining work using the company’s design control procedure, GMP, and quality management system.
- Conceptualize new design of spinal implant and instrument to meet customer needs and by incorporating human factors/usability engineering in the design process.
- Work closely with designer/drafter to generate models and prints using GD&T. Collaborate with manufacturing and external vendors to review prints and apply DFM (Design for Manufacturability) principles.
- Create rapid prototypes (e.g. SLA, FDM), metal prototypes, and proof of concepts.
- Evaluate the performance and feasibility of early concepts in lab and by conducting design of experiments
- Participate in risk management activities (e.g. dFMEA, pFMEA) and design activities such as Design Input, Design Output, Design Verification, Design Validation, and Design Transfer. Responsible to perform the Design Reviews and create the Design History Files documentation.
- Plan, conduct, lead, and report on significant development tasks for new Product Development projects. Manage the project timeline and ensure accountability to meet the key project milestones and deadlines. Effectively communicate with suppliers, internal/external customers, and all levels of management.
- Support Regulatory submissions, such as 510(k), from a technical standpoint.
- Support the cleaning, packaging, and sterilization validation activities. Manage the development of instrument trays and BOM.
- Participate in Material Review Board (MRB) and assist Quality/Regulatory in review of complaint and nonconformance. Support technical investigations, CCR, NCR, and CAPA.
- Develop novel innovations for inclusion in IP Portfolio. Support in the launch of NPD projects with Freedom to Operate (FTO) and competitive analysis.
Please forward your resume ASAP for consideration.
- Bachelor’s degree in Mechanical Engineering (preferred), Biomedical Engineering, or other relevant technical discipline.
- Four to seven years of relevant work experience (not including work studies or co-op) in engineering with two years of experience in the medical device industry (orthopedics, trauma, or spine). Prior experience in product development for a highly regulated industry is preferred.
- Have individual skills and abilities in the following areas:
- Self-starter, proactive, and accountable individual able to work independently or in cross-functional teams. Must possess good work ethics and the ability to align his/her tasks and priorities based on the company goals. Must possess excellent written and oral communication skills.
- Work experience using SolidWorks and experience with Product Lifecycle Management (PLM) software and familiar with Enterprise Resource Planning (ERP)
- Familiar with ISO 13485 and 21 CFR Part 820, specifically as the manufacturer of record of implantable devices.
- Capable of performing tasks and duties in support of the development of assigned Line Extensions, Product Upgrades, Specials, and New Product Development (NPD) projects using Regulatory compliant practices, software, tools, and procedures.
- Working knowledge of Intellectual Property including but not limited to: Patents, Trademarks, and Trade Secrets.