This role leads cross-functional new product development initiatives for in vitro diagnostic (IVD) assays and diagnostic instrument systems.
You will manage projects from initial concept through product launch within a highly regulated medical device environment.
The position combines strategic planning with hands-on execution across scope, timelines, resources, budgets, risks, and quality requirements.
You will work closely with Research & Development, Regulatory Affairs, Quality, Clinical Affairs, Operations, Finance, and Marketing teams.
Your leadership will help ensure product development milestones are achieved efficiently while maintaining compliance with applicable design control requirements.
You will establish clear project plans, drive accountability, identify critical paths, and facilitate effective decision-making across diverse stakeholders.
This is an opportunity to influence innovative diagnostic products while working in a collaborative, fast-paced environment with approximately 20% travel.
Accountabilities
- Partner with Research & Development, Operations, Regulatory Affairs, Quality, Clinical Affairs, Finance, Marketing, and other stakeholders to define project scope, objectives, deliverables, and success criteria.
- Lead cross-functional product development projects from concept through launch, ensuring activities remain aligned with business and product objectives.
- Develop accurate, achievable project plans, schedules, milestones, and timelines, and communicate them consistently to project teams and leadership.
- Drive ownership and accountability across project teams while recommending adjustments to plans, priorities, or resources when necessary to achieve project outcomes.
- Track project performance against short- and long-term objectives, proactively identifying risks, delays, dependencies, and opportunities for improvement.
- Ensure project tasks and deliverables are completed on schedule and in accordance with established procedures and applicable regulatory requirements.
- Facilitate cross-functional project meetings, establish clear actions and decisions, and maintain alignment among technical, regulatory, quality, clinical, and business stakeholders.
- Identify and manage critical paths to ensure key dependencies and milestones remain visible and appropriately prioritized.
- Support effective risk management, resource planning, budget oversight, and decision-making throughout the product development lifecycle.
- Maintain clear project documentation and provide timely status updates, performance reporting, and escalation of issues requiring leadership attention.
- Promote disciplined project execution within an FDA-regulated medical device development environment.
- Perform additional project management responsibilities as needed to support organizational and product development objectives.
- A Bachelor’s degree in Science, Engineering, Business Administration, or a related field is required; an advanced degree is preferred.
- At least 5 years of project management experience leading cross-functional product development projects is required.
- Direct experience managing product development projects within an FDA-regulated medical device environment is required.
- Working knowledge of medical device design control requirements and product development processes, including design planning, design reviews, and risk management.
- Demonstrated experience successfully managing products from concept through launch.
- Experience in the diagnostic, biotechnology, medical device, or related life sciences industry is strongly preferred.
- Experience developing or supporting in vitro diagnostic (IVD) assays and/or diagnostic instrument products is preferred.
- Familiarity with Quality Management Systems (QMS) compliant with FDA 21 CFR Part 820 and applicable medical device regulations is preferred.
- Project Management Professional (PMP) certification or an equivalent project management qualification is preferred.
- Demonstrated ability to identify and manage critical paths, dependencies, risks, schedules, and competing priorities.
- Strong problem-solving and analytical skills, with the ability to make sound decisions in complex and fast-moving environments.
- Self-motivated, detail-oriented, and highly organized, with the ability to balance multiple projects, workloads, and deadlines simultaneously.
- Ability to work independently while collaborating effectively with multidisciplinary teams and stakeholders.
- Strong interpersonal, organizational, written, and verbal communication skills.
- Ability to perform effectively under pressure and meet strict deadlines in a fast-paced product development environment.
- Basic understanding of device development, engineering, and manufacturing activities is a plus.
- Willingness to travel approximately 20% of the time as required to support project teams and key milestones.
- Opportunity to lead innovative diagnostic product development projects from concept through launch.
- Exposure to multidisciplinary teams spanning Research & Development, Regulatory Affairs, Quality, Clinical Affairs, Operations, Finance, and Marketing.
- Opportunity to work within an FDA-regulated medical device and in vitro diagnostic development environment.
- Position may be performed remotely within the United States or locally in Cincinnati.
- Approximately 20% travel to support project teams and important project milestones.
- Professional exposure to medical device design controls, regulatory processes, quality systems, and diagnostic product development.
- Collaborative environment focused on innovation, cross-functional teamwork, and solving complex product development challenges.
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
