Research and Development Manager

As the R&D Manager you will be responsible for the coordination of department and division activities during the product development process and management of assigned departmental personnel.

You will design, develop and implement new products, focusing on project planning, innovative medical device design, prototype development, testing characterization, analysis and reporting.

Main responsibilities will include:

• Product Development: Coordinates and/or directs all aspects of product development activity related to a product line, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering. Works with Operations and Supply Chain to deliver a new product to market in line with division and operational goals.
• Project Management: Creates and tracks project schedules, plans and budgets for the development of a new product (or line extension) and assesses department priorities. Makes assignments to direct reports to ensure projects and company priorities are met. Coordinates with cross functional peer and team members, internal and external suppliers and outside professionals to ensure department projects are developed to plan.
• Design to Manufacturing Transfer: Proposes and facilitates the selection of a new products manufacturing location. Oversees the transfer of new products to manufacturing locations.
• Design: Oversees the designs, development and implementation of new products and processes of a medical device. Oversee and contribute ideas and/or intellectual property submissions including but not limited to the development of new products and processes.
• Process Development: Oversees R&D project leaders, engineers and manufacturing teams in the development of develop new processes through the understanding key process inputs and outputs, including vendor selection and negotiation.
• Documentation: Review product development plans, design reviews, technical documents and reports. Review and approve verification and validation protocols and reports. Develops and implements department and division procedures/policy.
• Test Method Development: Oversee the development of clinically relevant test methods that adequately challenge new product design and processes.
• Testing: Oversee the planning and execution of qualification activities for new products and processes.
• Training: Train NPD teams, R&D technicians and engineers on new design and process development procedures as well as division procedures and policies.
• Supervisory/mentoring/coaching: Mentor/coach R&D teams through New Product Development activities. Typically supervises/manages R&D (project) teams, conducting performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions, and disciplinary actions.
• Fiscal: Creates, controls, manages a department budget (expense and capital expenditure). Critique engineering cost analysis. Reviews and analyses costs to identify and implement cost improvements.

Other Responsibilities may include, however are not limited to:

• Support Manufacturing, Quality, Regulatory and R&D to ensure systems are compliant with all internal and external guidelines.
• Support design and process root cause analysis and support non-conforming product and complaint investigations.

About you:

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline with Biomedical Engineering or Bioengineering degree preferred.
• 8+ years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
• Demonstrated knowledge of development, manufacturing and quality system requirements for medical devices or comparably regulated environment is required.
• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialisation; ability to execute validation.
• Ability to create and deliver project plans and lead multifunctional teams.
• Excellent oral and written communication skills, with strong, demonstrated skills in communicating with all levels of technical and operating management.
• Strong ability to analyse and use technical data and resources. Proficient in statistic software.
• Trained in Six Sigma or Design for Six Sigma.