Job Title: Senior R&D Manager

Location: (Bethlehem, PA, Bonita Springs, FL, Kenosha, WI, or Marquette, MI) - hybrid available

Department: Research & Development (R&D)

Reports to: Director of R&D or above

Description

The Senior R&D Manager is responsible for overseeing and driving an engineering team focused on new product development, sustaining and continuous improvement, and/or another specialty that's critical to the business. The Senior R&D Manager will provide guidance to their team, develop technical talent, align with cross-functional teams, and deliver best-in-class performance. This highly strategic role with broad organizational influence is a key part of ensuring overall business success.

Primary Responsibilities

•       Lead and develop a high performing team that can accomplish company and department goals. This may entail conducting activities in order to lead by example (ex: lead cadaver lab, author/review DHF documentation, etc.).

•       Ensure all product development activities are conducted in accordance with design controls and the company's quality management system, as well as additional customer specifications.

•       Communicate effectively and present project information and status when requested to ensure customers, project team, and senior management are aware of upcoming milestones and risks/issues.

•       Maintain project schedules by monitoring progress, coordinating activities with other departments, resolving problems, and recommending actions.

•       Before and after active development, assist other departments with activities like forecasting, quoting, purchasing, regulatory expansion, and/or post-market activities.

•       Promote and ensure continual improvement in all interacting departments.

•       Manage cost, resourcing, and performance of projects within your team.

•       Leverage internal and external teams to yield a strong technology roadmap.

•       Collaborate across divisions to obtain positive organizational returns and drive growth.

•       Organize data to manage and inform stakeholders of business decisions.

•       Ensure a positive return and healthy margins on projects and investments within the business.

Secondary Job Responsibilities

•       Support business development and management activities.

•       Support QA/QC and supervise first product builds.

•       Participate in trade shows, conferences, and supplier/customer visits.

•       Respond to field questions when necessary.

Educational/Experience Requirements

•       Bachelor's degree in mechanical or biomedical engineering, or a relevant engineering discipline or equivalent work experience.

•       12+ years of product development experience in the medical device industry is desired.

Knowledge/Skills Desired

•       Expert in CAD/Drafting (SolidWorks preferred), GD&T, FEA, DFM, and technical writing.

•       Experience with DHFs, ISO 13485, 21 CFR 820, and CE technical files.

•       Strong QMS knowledge (ex: leading CAPAs, reviewing PMCF documents, implementing continuous improvements).

•       Proven capability in managing relationships with customers and suppliers.

•       Expert in Microsoft Office and video conferencing tools, especially PowerPoint.

•       Effective communication, organization, and the ability to solve problems and make decisions.

•       Successful track record of bringing new products to market.

•       Ability to influence all levels within the organization and put together a cross-functional team.