Apply Now

Job ID: JOB-13382
R&D Manager – Product Engineering / Sustaining Engineering

Position Summary

This position is responsible for the coordination of department and division activities for post-launch maintenance of products, product development and management of assigned departmental personnel.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

▪ Post launch maintenance of products: coordinates and/or directs all R&D sustaining engineering activities including business continuity, change control, continuous improvement, and manufacturing support of assigned products.

▪ The position will oversee products which have been commercialized and projects/activities relating to them to include MDR related projects, 3rd party manufacturers, product engineering and sustaining activities.

▪ 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/maintain product to/in 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 product updates to capture design intent and transfer to manufacturing. Coordinates and participates in the transfer of new and existing products to manufacturing location(s) in coordination with manufacturing transfer leads.

▪ Design: Designs, develops and implements product and process improvements of medical devices, translating intangible design inputs into tangible engineering specifications in conjunction with cross functional team members.

▪ Makes and presents engineering decisions and provides project status reports.

▪ Leads cross-functional teams in the design of a medical device. Contribute ideas and/or generate intellectual property submissions including but not limited to that for product improvements, development of new products and processes.

▪ Oversee and contribute ideas and/or intellectual property submissions including but not limited to the development of new products and processes.

▪ Process Development: works with R&D engineers and manufacturing teams to develop new processes by understanding key process inputs and outputs, including specification development, vendor selection and negotiation. Documentation: write and review product development plans, design reviews, technical documents and reports.

▪ Prepares, reviews and approves 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 technicians and engineers on design and process development, and provide input to training of division procedures and policies.

▪ Supervisory/mentoring/coaching: Mentor/coach R&D technicians and engineers through Product Development/Improvement/Maintenance activities.

▪ Typically supervises/manages various members of a R&D department, conducting performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions, and disciplinary actions.

▪ Fiscal: Creates, controls, manages a department/project budget (expense and capital expenditure). Create and critique engineering cost analysis. Reviews and analyzes costs to identify and implement cost improvements. Other Responsibilities may include, however are not limited to:

▪ Support Manufacturing, Quality, Regulatory & 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. Required

Qualifications 

▪ B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering degree preferred.

▪ 7-11 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 5-8 years or Ph.D. degree with 4-6 years, medical device or equivalent industry experience). A minimum of 4 years’ experience in a supervisory capacity.

▪ 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 commercialization; ability to execute validation.

▪ Ability to create and execute project plans and lead cross functional teams.

▪ Excellent oral and written communication skills, with strong, demonstrated skills in communicating with all levels of technical and operating management.

▪ Strong ability to analyze and use technical data and resources. Proficient in statistic software.

Johanne Kennedy

JOB-13382

Apply Now