Senior Manager New Product Development

At Medicom, we have created an inclusive and diverse work environment where every employee is valued for the unique skills and perspective they bring to the team. Our employees make a positive impact on a daily basis and enjoy ongoing opportunities for personal and professional growth.

At Medicom, we live our core values of accountability, teamwork, customer centricity and empathy in everything we do. We are a highly collaborative team that takes “pride in protection” as we continue to provide healthcare and other professionals with some of the most reliable personal protective equipment and infection control products in the world.

Lead New Product Development (NPD) function to facilitate achievement of New Product Development objectives, New Product commercialization objectives, and overall enterprise strategic business objectives. Direct NPD project execution for all Medicom North American product lines and business initiatives. Manage execution of deliverables in support of phase-gate design controls NPD project plans to support business objectives. Determine and drive implementation of NPD strategy and roadmap. Identify and define NPD requirements for stakeholders throughout the company. Utilize risk-based critical thinking to assure compliance with design control process and associated quality/regulatory requirements. Lead and manage NPD process development using continuous improvement approach.

• Bachelor’s Degree in engineering, life sciences, quality/regulatory or related technical discipline
• 10+ years experience with progressive increasing management responsibility within regulated medical device NPD/R&D and/or life sciences discipline
• Travel domestically and internationally as required by business objectives, anticipated to be less than 25% of-time

Asset:

• Master’s degree and/or professional certification in scientific, engineering related technical discipline

• Direct NPD project execution for all Medicom North American product lines and business initiatives.
• Lead and manage NPD department resources to support achievement of business objectives.
• Oversee NPD departmental budget.
• Manage execution of deliverables in support of phase-gate design-controls NPD project plans to support business objectives.
• Ensure NPD project deliverables comply with applicable regulatory standard requirements including FDA QSR, ISO 13485, CDC NIOSH and EU MDR requirements.
• Manage and facilitate compliant, efficient and risk-based execution of phase-gate design controls NPD project deliverables, NPD engineering deliverables, New Product Development plans, coordinate verification and validation testing, provide inputs into regulatory planning process, manage execution of documentation to support compliance with design controls process including medical device design history files.
• Assist Product Development project portfolio management to assure portfolio continuously aligns with commercial strategy and available resource capacity/capability with objective and stable prioritization.
• Determine and drive implementation of NPD strategy and roadmap.
• Collaborate with executive management in determining departmental organizational plan, operating model, strategy deployment and governance procedures.
• Drive NPD process improvements and updates using continuous improvement approach.
• Facilitate achievement of business objectives using risk-based approach while ensuring compliance within the flexibility of the regulations.
• Lead high-performing team to support NPD functional objectives; facilitate organizational cohesiveness with the Medicom R&D operating model, business strategy and culture of quality and compliance.
• Drive efforts for design history file and/or related quality system or regulatory requirement remediation activities if necessary.
• Lead inspections and audits of design control documentation by applicable regulatory agencies including FDA, NIOSH and notified body.
• Manage execution of documentation control process tasks to support implementation design control process controlled documentation.
• Drive continuous improvement of design controls process, quality system and documentation processes to support business objectives.

Employer Medicom is an equal opportunity employer. We consider all applicants without regard to age, gender, gender identity or expression, sexual orientation, race, ethnic or national origin, religious beliefs, sex (including pregnancy and breastfeeding), disability or marital or family status. We welcome applications from all qualified individuals and encourage Indigenous persons, persons of color, LGBTQ+ and gender-nonconforming persons, persons with disabilities, women, and members of any other marginalized group.

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