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- Working with marketing, regulatory and operations to establish realistic timelines, deliverables and budgets for development projects.
- Working with managers, optimize R&D systems and processes to achieve timely, orderly and efficient flow of new product projects – from concept through product launch
- Providing clear, consistent and measurable direction regarding project timelines and deliverables.
- Ensure that R&D resources are appropriate to achieve the development goals.
- Motivate and mentor the team members to achieve a strong sense of urgency to develop and launch new products that are safe and effective, positively impacting the lives of patients.
- Clarify project goals and ensure that the product development plans fully capture:
- Performance requirements for patient treatment
- Design and quality requirements for the products
- Design controls – product and process
- BA/BS degree in mechanical or electrical engineering, physics or related disciplines, an advanced degree is highly preferred.
- At least 5 years of experience as a technical product development manager in a highly regulated industry such as medical devices.
- Must have experience in directing mechanical engineering activities, preferably in the development of class II and class III medical devices. (Some orthopedic experience a plus)
- Solid knowledge of R&D/Product Development processes, i.e. Stage Gate, Water Fall etc.
- Demonstrable success in developing and launching new products in a regulated industry, in complex environments
- Strength in DFSS (Six Sigma), Design Controls, mechanical hardware development
- Possess and able to instill a strong sense of urgency and initiative throughout the organization.
- Strong ability to motivate and develop employees
- Good ability to assess and maintain/improve business systems for new products development and commercialization.
Marissa E. Marsala | Founder
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