ADVANCED CLINICAL Looking for Director of New Product Development at Seattle, WA Full Time

OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as a Director of New Product Development in Seattle, WA. The Director of New Product Development role will have full responsibility for planning, designing, and executing new products from concept to launch, according to the company’s product roadmap. This position will be responsible for coordinating development activities across internal and external stakeholders and service providers, to ensure new products are developed on-time and within budget. Additionally, this role will be responsible for leading and executing all aspects of the product development process. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Coordinate development activities across internal and external stakeholders and service providers, to ensure new products are developed on-time and within budget.
• Lead product development teams in the “cradle-to-grave” development of new medical devices and product line extensions, as well as design changes to existing products.
• Scope and fully plan new development projects, including budget, timeline, resources and risks. Integrate cross-functional inputs from manufacturing, quality and regulatory teams as part of the planning process.
• Support a structured approach to product development, with an eye for compliance with the QMS and established NPD processes.
• Lead brainstorming and design reviews; create design concepts and technology for new products or improvements to existing products.
• Manage selection, training, development and performance management for the Product Development team. Assess and build the capability and capacity within the team.
• Direct and manage prototype manufacturing.
• Work with Operations to ensure smooth technology transfer and scale-up to commercial scale.
• Collaborate closely with Project Management to ensure structured processes are in place.

EXPERIENCE

• 10+ years of medical device product development leadership experience.
• Strong expertise with high volume, disposable medical devices. 
• Knowledge of medical device regulations (FDA, MDD/MDR), and related standards (e.g., ISO 13485). Experience with 510K and CE mark.
• Demonstrated experience in transitioning medical device product development programs to commercial manufacturing.

EDUCATION

• Bachelor’s degree required. Master’s degree preferred 

To be a best-fit your strengths must include:

• Strong project leadership skills. 
• Ability to prioritize and manage multiple projects/initiatives in a timely and cost-effective manner.
• Experienced and skilled in building, leading and mentoring teams.
• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Organized. You’re an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
• Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible. Detailed understanding of clinical methodologies and ability to provide sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

Equal Employment Opportunity
It is Advanced Clinical’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.