Manager, Product Development

at  Bausch Health Companies

Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.
We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.
We are all in it together to make a difference. Be a part of a culture that doesn’t just wait for change but actively creates it—where your skills and values drive our collective progress and impact.
Reprting to the VP, R&D, the Manager, Prodcut Development manages technical projects from initiation through product delivery. It serves as the primary liaison between technical and non-technical departments in order to ensure the rapid development of products achieve project objectives for scope, schedule, budget and product costs. This position also ensures project compliance with medical regulatory requirements.
This role requires substantial interaction across functional organizations of engineering and marketing, regulatory compliance, quality assurance, manufacturing, clinical training, and various technology partners, as well as, end user customer interface. Influence and time management skills are critical for success.
The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

Responsible for overall compilation and maintenance of design history for system definition, development, qualification, transfer and changes for a family of complex electro-mechanical equipment, and includes the following:

• Functional oversight of technical projects including the definition of product development plans, design activities and deliverables, schedules and budgets using bottom up planning methodologies
• Ensures product design and supporting documentation meet appropriate safety and regulatory compliance. Acts as primary driver for project execution in development and overall product life cycle management, as well as obtaining third-party certification for compliance as needed
• Primary liaison for the transfer of the product design into manufacturing from manufacturing prototyping through production validation
• Calls and conducts product level design reviews, build readiness reviews, pre-clinical and clinical readiness reviews
• Development and implementation of device instructions for use, ensuring output complies with applicable external regulatory authorities. Oversees design verification and validation by subject matter experts for language translation
• Works closely with suppliers to resolve build and delivery issues, as well as conducting supplier trade studies, evaluations, and second source efforts.

Experience, Education, Training, Traits:

• Bachelor degree in Engineering or equivalent experience. Master’s degree is highly desirable.
• Minimum of 5 years of product development experience specialized in medical equipment or capital equipment with complex electronics.
• Experience in developing products in a regulated environment (e.g., medical or Aerospace and IEC 60601-1 or RTCA-DO-160, ISO 13485, 14971 and 10987) is required.
• Strong understanding of project/program management is required with an understanding of developing PBS/RBS/WBS within a regulated FDA product development process.
• Multiple project orientation is required with strong acumen for execution and results.

Preferred:

• Familiarity Solidworks, Pro-E, OrCAD or Altium (schematics capture, PCB layout), PSIM, MATLAB/PSPICE or Comsol or Ansys or Pro-mechanica is a plus.
• Experience in the design and development process and deliverables of complex electro-mechanical systems
• Experience in Design Verification and Validation process of complex electro-mechanical systems against IEC electrical interfaces, power quality requirements, and EMI/EMC, safety and protection requirements and other regulatory requirements relevant to energy-based aesthetic medical devices
• Ability to gather information, analyze and present data to internal and external customers.
• Good business acumen and people skills
• Proficiency in technical specification development and documentation in a PDP environment.
• Excellent people negotiation and influencing/management skills
• Ability to influence people indirectly; i.e. persuade peers or engineers to which there is no functional reporting relationship to the urgency/priority of tasks and deadlines
• Effective communicator who can identify problems and provide timely cost- effective solutions.
• Ability to make timely/sound decisions and accurate judgments is essential.
• Ability to prioritize and plan work activities, use time efficiently and develop realistic action plans with multi-project orientation.
• Excellent work ethic

As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by many factors including skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $116K to $175K
Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.
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• Functional oversight of technical projects including the definition of product development plans, design activities and deliverables, schedules and budgets using bottom up planning methodologies
• Ensures product design and supporting documentation meet appropriate safety and regulatory compliance. Acts as primary driver for project execution in development and overall product life cycle management, as well as obtaining third-party certification for compliance as needed
• Primary liaison for the transfer of the product design into manufacturing from manufacturing prototyping through production validation
• Calls and conducts product level design reviews, build readiness reviews, pre-clinical and clinical readiness reviews
• Development and implementation of device instructions for use, ensuring output complies with applicable external regulatory authorities. Oversees design verification and validation by subject matter experts for language translation
• Works closely with suppliers to resolve build and delivery issues, as well as conducting supplier trade studies, evaluations, and second source efforts