nirrin is at the forefront of developing sensors and analytics to make medicines easier to make. We are dedicated to delivering bioprocess insights for greater clarity and confident decision making for the development and manufacturing of biologics and advanced therapies.
Our small but passionate team is focused on integrating novel near-infrared sensors with other data sources to enable the next generation of biopharma manufacturing. We provide customer focused innovative solutions to the challenges faced by the biopharma industry as a whole. At nirrin, we believe in fostering a collaborative and supportive work environment where our team can thrive and make a meaningful impact.
We are looking for a front-end developer to help build awesome looking and easy to use interfaces for our instruments.
This role will be onsite working out of the Billerica office.
About the Role
The VP of Product Development will have responsibility for direction and oversight of development of Nirrin’s product platform from charter through launch and lifecycle management. This role will have responsibility and oversight of the Engineering, Manufacturing, Lifecycle Management, and Sustaining Engineering efforts for Nirrin. The qualified candidate will demonstrate the ability to lead senior technical staff and people leaders managing technical teams of mechanical, software, electrical, and data scientists, working with all internal and external personnel and resources required to transfer new products and features to Nirrin’s product portfolio.
The VP of Product Development will demonstrate expertise and skills required for these efforts, as well as develop them within the team. This individual will work closely with Research, Commercial, Operations, and Quality/Regulatory Leadership to oversee Nirrin’s Product Development strategy and execution.
The ideal candidate will be a high energy, confident individual possessing strong analytical and communication skills with an M.S. in an engineering discipline, with at least 15 years of industry experience developing, manufacturing, and commercializing and at least 7 years managing technical teams and managers.
[Note: we would be open to considering candidates with additional experience for a more advanced role, e.g.Head of Product; VP of Engineering; VP of R&D.]
- Manage 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 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.
- 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 (process equipment or process development) 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 trouble-shooting 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
- Creative and adaptable in identifying and implementing best practices across 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.