Empowering people, creating technology.

Responsibilities:

• Plans, directs, and implements all aspects of the company's design and development of new medical device products and processes both internally and externally with clients.

• Leads the development of the strategy for the Product Development department, budget, P&L while ensuring links to the company’s aims and objectives.  Instilling a sense of urgency and accountability to the Product Development teams ensuring business objectives are met.

• Has accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives.

• Drives innovation across the business area, encouraging best practice and knowledge sharing. Leads team in continuing to advance internally developed IP and overall advancement of the Prop Tech platform.

• Communicate with key client sponsors on a regular basis (as required) and provide updates to Management in a timely manner. Establish and foster key client relationships through consistent communication and active Program involvement.

• Ensure client issues/deviations are resolved and documented in a timely manner including variances in program budgets, plans and schedules with clients, Business Development and Management.  Negotiate necessary changes with clients.

• Provide capital and human resource recommendations with supporting justification that will further enable the Company’s ability to execute in Product Development.

• Monitor customer program milestones and proactively address areas of concerns. Actively participate in product design reviews, technical device reviews and critical program gating events.

• Work with PMO in establishing, negotiating and maintaining project budgets including out-of-scope activities.

• Oversee and understand project risks ensuring mitigation and contingency plans are established and activated as required.

• Assure design outputs from the team meet the program’s quality system and external regulatory compliance.

• Oversees the team’s investigation and evaluation of existing technologies and guides the conceptualization of new methodologies, materials, machines, processes, or products.

• Develops, evaluates, implements, and maintains technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.

• Significantly improves, changes, or adapts department processes, systems, products, or services to meet the needs of the business.

• Communicates and conducts briefings with senior or executive leadership regarding ongoing operations and strategic initiatives.

Qualifications:

• Bachelors Degree in Engineering

• MBA or the educational equivalent preferred

• Minimum of 8 – 10+ years of Product Development Engineering experience in the Medical Device Industry and 7+ years of managerial experience.

• Experience leading a large team across multiple locations.  Coaching and Mentoring individuals. 

• Minimum 5 years of qualified business management experience in the areas of project management, financial management and technical personnel management.

• Experience working cross functionally at a leadership level to drive organizational alignment.

• Experience developing and commercializing medical devices with a comprehension of regulatory path requirements, design controls, QSR and product development phase approach.

• Demonstrated experience preparing material for presentation to executives and delivery of said material.

• High degree of initiative and self-motivation.

• Strong, effective, and servant leadership.

• Ability to adapt quickly to changing conditions and resolve conflicts in the department and across cross functional groups

• Ability to travel as required – average 25%.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Medical LLC