Manager, Product Development

Date: Sep 23, 2022

Location: US-WA-Bothell, Washington, US

Company: Bausch Health

This position 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.

 

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

 

Language and Verbal Skills
Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, specifications, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and status to project team members.

Math Skills
Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to use MS Excel to perform calculations and interpret project results/data.

Analytical and Reading Skills
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to read regulatory, technical and clinical literature and documents and extract important concepts.
 

Physical Requirements

Duties of this job may involve standing and/or walking for extended periods of time.  Duties might also involve daily keyboard data entry.

 

Work Environment

The noise level in the work environment is usually moderate.  Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure.

 

Safety

Solta Medical is committed to the health and safety of our employees.   We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.