Product Launch and Sustaining Manager

Reporting directly to the Director of Scientific Affairs, the Product Launch and Sustaining (PLS) Manager is an important leader within the Scientific Affairs department and company. The PLS Manager is responsible for coordinating changing day to day priorities to ensure the maintenance of existing product designs and the smooth transition of new designs from R&D to production.

You have a track record of successfully managing a team dealing with multiple projects at once, requiring agility and speed to ensure successful delivery of the projects. These projects would include design transfer, from design development to regulatory submission to large scale manufacturing, and day to day projects for existing products that must be executed in a timely manner to ensure company goals can be met. This must all be done while ensuring products are meeting company, quality and customer expectations.

To ensure success in the role, you’ll need to have strong planning and strategic prioritization skills, excellent team management, be an effective problem-solver so roadblocks can be removed and be a technical expert so you can provide technical advice to team members.

In this role, you’ll live the core values through and through.

**HOW YOU WILL CONTRIBUTE**
- Work closely with the R&D, Engineering, Regulatory, Quality and Production to drive the successful transition of new products from early development to product release.
- Use your skills and experience to lead your team to implement design for manufacturability into new designs and design changes, without compromising the performance or quality of the product to ensure success when transferring to production
- Build strong cross-departmental relationships to ensure collaboration within projects and gain the ability direct decision making through gained trust.
- Manage the day-to-day operation within the PLS team, directing projects and managing personnel
- Manage the development of new R&D manufacturing processes and the scale up of those processes into high volume manufacturing
- Manage the process validation of new, or modified, manufacturing processes using industry standard methods
- Work with the quality and manufacturing teams to translate design inputs into procedures, test methods and quality control release criteria for large scale production
- Provide expertise on design control activities and assist in the design and documentation for new and existing products, including but not limited to
- design requirements from a manufacturing point of view
- manufacturing specifications are correctly developed and include all critical elements to ensure consistency in the manufacturing
- development and execution of design verification and validation test plans for the retesting of existing designs
- design and execute required stability studies
- design history files and device master records post product launch
- risk management activities related with the product and manufacturing processes
- Review, analyze and summarize data and write reports as needed, including assisting with regulatory submissions
- Perform onboarding of new talent, training, team schedules, team goals with performance management to enhance team performance and skill development

**WHAT YOU BRING**
- Master’s or PhD degree in a life sciences, engineering or manufacturing disciplines, with a minimum of 3-5 years’ supervisory experience in a medical device industry environment. BSc or BEng with additional industry experience will be considered.
- Knowledge of and experience with GLP, GMP work and ISO 13485
- Strong technical knowledge of IVD test design, development and manufacturing is a strong asset
- Experience with team management and resource planning
- Excellent interpersonal skills, oral communication skills, and written communication skills are required
- A can-do, winning attitude and demonstrated track record of being a strong leader
- Must have strong analytical and technical writing skills
- Must be able to direct a team, setting expectation, goals, and milestone to ensure successful delivery of project
- Must be a strategic thinking and planner, migrating potential problems before they happen
- Be results driven, organized and detail-oriented
- Have excellent computer skills (MS Office, Access, Excel)

**WHAT WE OFFER**
- A competitive compensation package
- Extended health benefits including dental - 100% employer contribution
- Flexible working hours
- Paid sick days
- Bonus day off with pay on your birthday every year
- Full-size in-house fitness gym and shower facilities
- Complimentary reserved parking
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
- A chance to show off your dance moves and singing voice at the company parties and jump in to score a victory or lead the way in our outdoor games at the summer barbeques
- The opportunity to join an ‘off the charts’ foodie culture in our large kit