Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Location/Division Specific Information

Onsite Marietta, Ohio or Pittsburgh, PA

About the role:

Manages the Product Commercialization Process (PCP)/new product develop

ment and introduction through the phase-gate process, managing scope, schedule, risks, issues, trade-offs, communications, and expectations.

Represents the organization in assuring the teams follow product development best practices, and adhere to specific regulatory requirements, as they lead project teams through PCP. This includes assuring design control and thereby long-term product supportability, as well as delivering the business value.

Lead with the goal of not only delivering a product of high quality and value to the organization, but delivering within the agreed upon project contract metrics of schedule, resources, budget and scope.

A day in the Life:

• Lead, manage, coordinate, synchronize, and be accountable for the execution of programs from Customer engagement through to Product Delivery / Launch & Program Closure.
• Manage multiple projects/programs simultaneously, ranging in complexity and scope
• Act as information bridge between the Core Team and Senior Management. Influence stakeholders in a highly matrixed organization.
• Lead teams to define and prioritize scope, objectives, and requirements.
• Develop accurate, actionable, and cross-functionally integrated program plans based on business goals, constraints, and risk tolerance.
• Drive risk assessment, communication, proactive mitigation planning, and contingency response planning.
• Regularly track, monitor, and communicate team progress against requirements and plans to all Stakeholders; resolve deviations; schedule and lead core team meetings.
• Collaborate and coordinate across all the functional areas (R&D, Product Management, QA/QC, Regulatory, Legal, Operations, Manufacturing, Service and Support and others) to ensure successful program completion.
• Lead, document, and communicate constructive lessons-learned analysis of completed programs.

Requirements:

Education:

Bachelor's degree in engineering, life science, business or related field of study. Advanced degree is a plus

Experience

• Minimum 8 years of product development experience in Life Sciences, Biotechnology or Medical Devices; IVD experience highly preferred; experiences in instrument or hardware system integration highly preferred
• Minimum 5 years of program management experience.
• Phase-gate product development process experience.
• VOC process experience preferred.
• PMP certification preferred.
• Agile certifications advantageous.
• Proficiency with MS Project Management software and MS Office suite

Knowledge, Skills, Abilities

• Highly accountable, demonstrated ability to influence and promote accountability in matrix environments
• Strong technical knowledge of regulated product development processes and quality systems
• Ability to distill, prioritize, and act on feedback from a variety of sources.
• Excellent critical thinking, troubleshooting, crisis management, and decision-making skills.
• Excellent leadership skills particularly stakeholder management and leading without authority.
• Excellent oral and written communication skills.
• Ability to collaborate effectively across diverse cultures and global teams.
• Meticulous attention to detail and a passion for driving execution at a detail level when vital while maintaining the ability to see the big picture.

Additional Qualifications

• PPI (Practical Process Improvement) certification or experience preferred.
• Strong understanding of KPIs, tiered management systems, and strategic performance measurement.
• Awareness of market dynamics, customer workflows, and go-to-market strategy principles.

Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• Paid time off, paid holidays annually, paid parental leave, accident and life insurance, and short- and long-term disability in accordance with company policy
• 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount