VISTA DENTAL PRODUCTS Senior Product Development Engineer in RACINE, Wisconsin

JOB REQUIREMENTS: Job responsibilities Vista Dental Products, a manufacturer and developer of medical and dental products, has a new and exciting position for a Senior Product Development Engineer. This position will involve all aspects of medical product design and support, including: FDA/ISO Compliance, Quality Assurance, Project Management, Manufacturing, Intellectual Property, Research & Design, and Verification / Validation. The ideal candidate will have prior medical device product development experience and be a self-starter that is comfortable multitasking and able to adapt to various responsibilities. They will also exhibit the following personal traits: inventive, measurement and analysis skills, attention to detail, ownership of projects, and design skills. Specific responsibilities will include but are not limited to: Lead activities associated with the design and development of new products, specialty products, 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 clinicians and KOLs throughout the conceptualization and development phases. Lead development sessions and actively participate in focus groups to obtain critical project input. Conceptualize new design of dental products and solutions 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. 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 by conducting design of experiments. Participate and lead 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. 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. Participate in Material Review Board (MRB) and assist Quality/Regulatory in review of complaints and nonconformances. 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. Other duties as assigned by Executive Management. ***** OTHER EXPERIENCE AND QUALIFICATIONS: Required Qualifications Bachelors degree from an ABET accredited university in Engineering, with a preference towards Biomedical, Bio-Engineering, Bio-Molecular or other Engineering degree with a focus/concentration on medical engineering 3-5 years of experience in the medical device industry Proficient oral, written, and presentation skills Legally authorized to work in the U.S. Preferred Qualifications Previous research, co-op, internship, or i ndustry experience Advanced degree in engineering (MS or PhD) Chemistry knowledge, familiarity with analytical techniques (titration, etc), wet lab experience, and lab safety (GMP/GLP) Electronic design and familiarity with circuits ***** APPLICATION INSTRUCTIONS: E-Mail a Rsum: hrobedeau@vista-dental.com