Job Description & How to Apply Below
Duration: Permanent, Full-time
Our client is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. The device systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients
Our client offers an open, creative and casual working environment and has excellent reviews for working environment and team members. They believe that diverse ideas, opinions and perspectives will build a strong foundation for success
We are looking for a Director of R&D to lead a technical department in R&D organization within the field of Respiratory and Surgical Solutions. The R&D director will play a pivotal role in growth through innovation of new technologies and enhancing current platforms. This will include liaising with Marketing to understand customer problems and evolving products from concept to commercialization. The chosen candidate will drive unique innovation to build a set of core technology assets that can be customized to provide multiple customer solutions.
Lead a technical department in R&D comprised of Mechanical, Electrical, Software engineers, as well as other technical and scientific disciplines as programs may require.
Lead all launch initiatives for R&D including driving any necessary course correction to ensure deliverables will be met.
Partner with other cross-functional stakeholders to ensure commercial and financial success,
Direct research efforts for internal products and as appropriate, integration efforts for acquired technology in conjunction with senior management.
Frame programs from idealization to commercialization, launch dates and post-launch, prepare detailed program investment estimates, present programs for approval and deliver programs to time and investment commitments
Lead programs through the development process, in close partnership with marketing, sales, quality and senior management. Manage to milestone deliverables as defined by the PDP process and as approved by senior management.
Ensure conformity to FDA 21 CFR Design Control and Risk Management throughout the program’s development.
Develop business case rationale for resourcing needs, manage departmental budget, and workforce planning efforts to meet business need on time and within budget.
Assist with M&A activities in partnership with senior management. Provide valuation and technical insight on external offerings as requested
Partner with Quality, Customer Care, Tech Services and Sales personnel to drive continuous improvement in Cost, Quality and Reliability of instruments throughout their life cycles.
Routinely interacts with key engineers, organization leaders, customers, and suppliers
Bachelor of Science in (Electrical, Mechanical, Software, System) engineering.
Advanced degree such as master’s or PhD is preferred. Having MBA is an asset.
8+ years of managing technical teams through development
5+ years experience leading development efforts within a defined PDP and stage gate review process, preferably in partnership with cross-functional peers in Business Unit settings
Strong understanding of mandated regulatory and quality parameters within a heavily regulated industry (medical, telecom, etc.).
Successful track record of delivering instruments within a world class Design Control system.
Excellent program management skills and proven track record of delivering products on time and within budget. Deep understanding of Mechanical, Software, Hardware Engineering and Systems Integration. Video/Camera/Imaging experience is a plus.
Proven track record of successfully delivering programs through FDA pre-IDE evaluations, 510K certifications and related premarket approvals is an asset.
Experience with working with large OEMs and CMs to support of high quality and high volume products
Strong business acumen and communication skills with ability to interact at all levels/functions of the organization.
Experience developing/processes using new technologies and processes
Apply today for immediate consideration or contact for further information.
Less than 1 Year
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