Senior Program Manager - Katalyst Healthcares & Life Sciences

• Manage the entire product lifecycle, including initiation, planning, execution, monitoring, and launch for new medical device products within the chemical and life sciences domains.

• Maintain timeline adherence and align project objectives with business goals.

• Ensure that all project phases comply with medical device design controls and regulatory requirements, such as 21 CFR 820 and ISO 13485.

• Drive risk management processes to address potential issues proactively.

• Partner with engineering, marketing, regulatory, and manufacturing teams to achieve project milestones.

• Lead and coordinate efforts of both on-site and offshore teams, including external vendors.

• Implement Lean Business Systems tools and methodologies, including Visual Project Management, Daily Management, and Kaizen, to enhance process efficiency, reduce waste, and promote a culture of continuous improvement.

• Analyze complex data to identify root causes of challenges, develop effective solutions, and prevent recurrence.

• Apply advanced problem-solving techniques to drive issue resolution.

• Communicate project status, risks, and key decisions to stakeholders at various levels, aligning project efforts with organizational priorities.

• Influence stakeholders through data-backed insights and effective communication.

• Demonstrated success in the management of complex projects in Engineering/Technical field.

• Excellent problem-solving skills with the ability to analyze complex data, identify root causes, and develop practical solutions.

• Track record of leading others to pursue challenging goals and to challenging the status quo to develop breakthrough solutions.

• Strong interpersonal and communication skills, with the ability to effectively collaborate with cross-functional teams and influence key stakeholders.

• Ability to lead Onsite and offshore teams from different vendors and within organization.

• The ability to set high standards for results (refuse to fail mentality), and once achieved, raises the standards even higher. Holds people accountable for meeting commitments and getting results.

• Creates an environment that encourages risk-taking and ensures inclusion of varied perspectives.

• Metric driven attitude with high level of accountability for performance.

• Proficiency in project management tools and software.

Requirements:

• Bachelor's Degree.

• Master's Degree.

• PhD Degree.

• Bachelor's Degree in technical or technology related field required. Preferred Advanced degree (master's degree or Ph.D.).

• 7-10 years of related PM experience, at least 3 years' experience in the Medical Device industry field required.

• Experience launching new Chemical and Life Sciences products to market from concept to launch.

• Minimum of 5-7 years of related professional experience with process improvement, metrics and project management leveraging continuous improvement tools and processes.

• Preferred prior experience in Lean Business Systems tools and processes, such as Visual Project Management, Risk Management, Daily Management, Problem Solving and Kaizen.

• (Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.).

• Knowledge and application of design controls within the framework of Medical Device Regulations (21CFR820, ISO 13485), ensuring that every design step meets the rigorous standards required in the medical device industry. Strong business acumen with experience in understanding ROI evaluation.

• Proven track record of successfully leading Engineering/Technical projects to deliver on objectives.