VP of Product Development

About the position

The VP of Product Development at Nirrin Technologies is responsible for overseeing the development of the company's product platform from inception through launch and lifecycle management. This role involves leading a team of technical managers and engineers across various disciplines, ensuring the execution of product development, engineering, and quality assurance in a highly regulated environment. The VP will collaborate with multiple departments to define product needs and drive innovation in biopharma manufacturing.

Responsibilities

• Manage a team of technical managers, directors, and individual contributors leading multi-disciplinary engineers, scientists, technicians, and other personnel.
• Ensure execution of product development, engineering, software, manufacturing, and quality assurance of all products within a highly regulated environment.
• Require and deliver quality throughout the team, product, and manufacturing processes consistent with international standards (e.g. ISO 13485, GMP, 21CFR, GAMP5).
• Manage product development and engineering planning, including product, software and technology roadmaps, execution, budgeting, resource planning, process development, technology transfer, vendor partnerships, and performance metrics.
• Collaborate with other leaders, including Technology development, Research, Operations, Commercial, Quality, and Regulatory, to define needs, constraints, and opportunities.
• Demonstrate and support Design Excellence / Six Sigma approach of advanced experimental and analytical techniques in design, development, and manufacturing of the systems.

Requirements

• B.S. in engineering discipline, preferably mechanical, biomechanical, or electrical engineering.
• At least 15 years of industry experience with a medical device, diagnostic, or pharmaceutical company.
• At least 7 years managing technical teams, including at least 3 years managing people leaders.
• Experience launching products within US FDA GMP/GLP, ISO13485, CE, and other regional regulations and requirements.
• Familiarity and experience working in a regulated environment and building products according to Industry Standards.
• Familiarity and demonstrated excellence developing and manufacturing complex electro-mechanical systems and consumable products.
• Strong organizational, analytical, problem-solving, root-cause-analysis, and troubleshooting skills.
• Strong written and verbal communication skills.
• Ability to lead and motivate a highly skilled and diverse team of engineers and technical people leaders.
• Ability to work within a diverse workforce and provide a positive and motivational work environment.
• Scientifically motivated with the ability to design, conduct, and analyze experiments.
• Entrepreneurial and comfortable in a fast-paced environment.
• Ability to adapt to shifting constraints while maintaining high performance and morale.
• Self-motivated and collaborative, with excellent time management skills.
• Creative and adaptable in identifying and implementing best practices across the team.
• Demonstrated leadership ability to exemplify nirrin's values of: Curiosity, Innovation, Conviction, Enthusiasm, Accountability, Transparency, and Integrity.

Nice-to-haves

• M.S. or other advanced degree in engineering discipline.
• Cell and gene therapy device manufacturing experience preferred, but not required.
• Six Sigma certification.
• Project Management experience, including PMP certification.

Benefits

• Competitive salary based on experience
• Collaborative and supportive work environment
• Opportunities for professional development