NPI Program Manager

Position Summary
The NPI Program Manager leads the cross-functional engineering team for new product introduction, coordinating all facets of product development from project inception through hand-off to production. The Program Manager is responsible for meeting program goals and objectives, managing the program financials and project timelines, customer communication, and managing project scope. This is an indirect leadership role with no direct reports.

Accountabilities & Responsibilities

• Administer and manage product development projects through the new product engineering stage gate process to meet requirements, scope, schedule, budget, and quality expectations
• Ensure compliance to the company Quality Management System (QMS), policies and procedures, regulatory agency standards and guidelines, and customer specifications throughout the development cycle
• Build and maintain a positive working relationship with internal and external customers
• Direct and assume responsibility for the actions and performance of the NPI cross-functional team. Facilitate teamwork between departments
• Create project plans/timelines and promote a sense of urgency to ensure successful commercial launch
• Work closely with project team members to meet or beat product development milestone delivery dates
• Understand manufacturing capabilities and capacity of the organization
• Understand manufacturing and engineering processes that relate to the medical device industry
• Support estimating efforts for company products and services
• Lead discussions with internal teams on designs, troubleshooting and finding cost-effective solutions
• Manage/facilitate transfers to production
• Communicate with internal stakeholders on a routine basis and provides project plans, timelines, and milestones
• Proactively recommends, promotes, and supports actions for implementing continuous improvement projects
• Assists internal teams with cost reductions, root cause analysis, and corrective actions
• Interact with clinical teams and patient representatives during product usability studies as needed
• Perform other duties as identified by management to support corporate objectives
• Perform all job duties while maintain HIPPA requirements

Education & Experience

Required:

• BA/BS degree in science or another technical field
• 4+ years of experience in manufacturing and/or engineering role
• Experience managing numerous projects simultaneously using appropriate software tools (i.e. Excel or Microsoft Project) and professionally communicating project status to all levels of the organization
• Medical Device Quality Management System (QMS) experience including 21CFR820, ISO 13485, MDSAP, and FDA regulations

Preferred:

• PMP or similar project management certifications
• Previous experience with medical device product development and manufacturing
• Understanding of Electronic Assembly, Finished Good Kitting, and Distribution logistics
• Previous experience with improvement tools such as Six Sigma, Lean manufacturing

Knowledge & Skills

• Strong written/verbal communication and presentation skills to clearly articulate concepts
• Ability to work cross-functionally to solve technical problems
• Demonstrated ability to meet project deadlines
• Ability to make timely decisions based on stakeholder input and engineering fundamentals
• Organization and prioritization skills - adaptable to changing business needs and adept at juggling numerous projects
• Demonstrated problem solving skills and analytical abilities
• A passion for continuous learning
• Ability to collaborate with both technical and non-technical team members Statistical analysis
• Strong proficiency with Microsoft Office tools including Word, Excel, PowerPoint, Teams or other relevant software
• Ability to adapt to changing environments and effectively manage change by providing hands on enthusiastic leadership
• Ability to prioritize and deliver on key initiatives; demonstrated success in achievement of key performance metrics targets within time and budget constraints
• Ability to Influence and collaborate across all functions/level of the organization as well as external regulators

Competencies:

• Leadership
• Continuous Improvement
• Critical Thinker
• Planning
• Communication
• Project/Process Management
• Priority Setting
• Peer Relationships
• Problem Solving

It is the policy of Tactile Medical to provide equal opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Tactile Medical will provide reasonable accommodations for qualified individuals with disabilities.