Our Mequon area client has a "Direct Hire" role open for a Senior Product Development Engineer.
The Senior Product Development Engineer is responsible for the design and development of new and improved products using the company’s design control procedure and in compliance to the quality management system.
The Engineer is responsible to execute the design and development activities throughout the product development lifecycle, from cradle-to-grave. In addition, provides technical guidance and coaching for junior engineers.
Must possess and apply knowledge of medical device engineering principles, practices, and procedures.
Also responsible for maintaining compliance to industry guidelines, GMP, regulatory requirements, and maintaining Design History Files for new and legacy products.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
QUALIFICATIONS AND REQUIREMENTS:
- Lead activities associated with the design and development of new product, specialty product, and sustaining work using GMP, the company’s design control procedure, and quality management system.
- Responsible for complex new product development projects. Lead a cross-functional team throughout the project lifecycle, from concept to launch.
- Ownership of the project plan, project management, and key deliverables. Participate in the budget planning cycle for the projects.
- Participate actively with Marketing and Sales to define customer needs. Engage surgeons and KOL throughout the conceptualization and development phases. Lead development sessions and actively participate with surgeons to obtain critical project input.
- Conceptualize new designs 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 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 lead 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. Serve as technical leader within the product development team.
- Form strategic partnerships with suppliers to optimize technologies, quality, cost, and lead-time. Provide COGS estimates and work with Finance and Marketing to refine business case.
- Support Regulatory submissions, such as 510(k), from a technical standpoint.
- Lead cleaning, packaging, and sterilization validation activities. Manage 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. Perform assessment of competitive landscape in support of projects, development pipeline, and competitive library/matrix.
- Collaborate with Sales and Marketing to develop technical tool, training program, and marketing collateral.
- Other duties in support of Sales, Quality/Regulatory, Logistics and Supplier interface, Operations and general business operations may be assigned as resource needs require.
Please forward your resume ASAP for consideration.
- Bachelor’s degree in Mechanical Engineering (preferred), Biomedical Engineering, or other relevant technical discipline. Master’s degree is preferred.
- Eight + years of hands-on product development with design control and regulation experience developing medical devices (i.e. Orthopedics, Trauma) models, implant / instrument systems, and project oversight.
- Proven mentoring and leadership skills and able to adapt to the dynamic needs of a small company.
- Must lead by example and possess strong work ethics.
- Ability to drive accountability without formal authority.
- Ability to coach junior engineers and interns.
- Excellent mechanical/mechanism design aptitudes, and problem solving/analytical skills.
- Proficiency using SolidWorks and Hands-on experience with Finite Element Analysis (FEA) is desirable.
- Experience using Product Lifecycle Management (PLM) software and Enterprise Resource Planning (ERP).
- Experience working per ISO 13485 and 21 CFR Part 820.
- Capable of performing and leading 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.
- Able to develop project plans and drive projects to completion according to the timeline and with accountability.
- Experience in interactions with Sales, Marketing, Surgeons and industry professionals in development of concepts, designs, and improvements for existing products.
- Working knowledge of Intellectual Property including but not limited to: Patents, Trademarks, and Trade Secrets.