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Klein Hersh

Vice President of Product Development

Klein Hersh, Tempe, Arizona, us, 85285

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Our client is a clinical-stage biotech company pioneering novel therapies with a potential to treat aneurysmal disease and improve patients lives. The Vice President of Product Development will play a pivotal role in leading our product development efforts and will be responsible for overseeing the entire product lifecycle, from ideation and concept development to commercialization. Key Responsibilities

Responsible for the development and execution of a comprehensive product development strategy aligned with the company's overall business objectives. Build, manage, and inspire a high-performing PD functional organization, fostering a culture of innovation and collaboration, with focus on:

Talent and skill development Organizational health, workforce planning, and employee experience

Oversee all aspects of the product development process, including research, design, development, testing, and manufacturing. Work with contract manufacturers on product design, development, testing, and manufacturing. Manage multiple product development projects simultaneously, prioritizing tasks and meeting deadlines effectively. Serve as a key member of our client's Leadership Team, defining and owning solutions to business challenges and opportunities. Deliver on our client's initiatives through on-time/on-budget delivery of iterative and new products, set and enable R&D NPD business objectives, drive innovation, and accelerate product introduction. Ensure compliance with all relevant regulatory requirements, including FDA, CE, and other applicable standards. Work with physicians, the clinical team, and medical science to solicit input and incorporate relevant feedback into product design. Collaborate closely with cross-functional teams (e.g., clinical affairs, medical science, marketing, engineering, and manufacturing) to ensure successful product launch, commercialization, and adoption. Lead product related investigations (NCRs, CAPAs, Complaints, etc) and root cause analyses, developing and implementing corrective actions. Manage design controls internal to our client and with external vendors. Key Requirements

Advanced degree in engineering, biomedical engineering, or a related field. Experience in aortic medical device development. Minimum 10 years of experience in product development, preferably in the medical device industry. Strong track record of leading successful product development teams, execution, and respect for project governance and delivery of predictability. Deep understanding of regulatory requirements and quality assurance standards. Excellent project management skills and ability to manage multiple projects simultaneously. Highly influential strategic thinker with strong business acumen and experience partnering with other business and functional leaders to drive portfolio optimization.

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