Principal Process Engineer

Job Responsibility:

The Big Picture

As our team experiences rapid expansion, we are actively seeking a Principal Process Engineer to join our innovative team. The ideal candidate will play a pivotal role in developing and optimizing manufacturing processes for medical devices. Key responsibilities include mentoring junior engineers, driving process innovation and optimization, and collaborating with various departments to deliver cutting-edge technical solutions. Your experience will be critical in ensuring compliance with regulatory standards and advancing our mission to improve patient care through advanced medical device technology. The successful candidate will have a proven track record in process development within the catheter-based medical device industry.

At Baylis, we offer challenging and meaningful careers for individuals inspired to work in the biomedical industry. Our team consists of intelligent and success-driven individuals with a strong inspiration to improve the lives of others.

Impact Through Innovation

• Led process development on path-breaking NPI development projects, working as part of the project team.
• Development and installation of new manufacturing and process technologies to support product development and product transfers.
• Apply new technologies and methodologies to optimize process design & performance.
• Establish processes based on product specifications in line with Unit Cost metrics.
• Evaluate process and design alternatives based on Design for Manufacturability principles.
• Apply principles of lean manufacturing, problem-solving, and DOE.
• Complete process validation for new processes and products, including IQ, OQ, PQ & PPQ.
• Working with external vendors to specify, develop, and commission new process technologies.
• Setting up of new manufacturing equipment/production lines including the selection and training of process technicians and product builders, as required.
• Develop manufacturing processes from prototyping to full-scale production
• Initiate and complete technical activities leading to new or improved products or processes for current programs and next-generation programs.
• Identify process risk and drive mitigation strategy
• Responsibility for and understanding of work environment issues including H&S activities associated with new process development.
• Development of manufacturing processes from prototyping to full-scale production.
• The manufacture and testing of prototypes.
• Design/Source Equipment and Tooling required to meet both the capability & capacity requirements
• Generate work plans & schedules for development activity and execute to plan.
• Lead process validation and equipment qualification activities.
• Support and mentor Junior engineers.
• Adhere to all requirements of the Quality Management System.

Your Unique Expertise

Required Skills:

• Degree or equivalent in an engineering discipline, with 9 yrs+ experience with manufacturing process design and optimization within a highly regulated environment
• Proven ability to conceptualize and deliver automated solutions as needed
• Experienced in using Six Sigma methodology for process improvement (e.g. DMAIC) and problem-solving
• Advanced skills in statistical analysis and use of Minitab
• Strong knowledge and ability to teach Design of Experiments
• Demonstrated experience leading and mentoring technical teams
• Excellent proficiency in SolidWorks
• Exception oral and written communication skills for engaging with various organizational levels
• Proficiency in two or more of the following processes: laser welding, reflow technologies braiding, coiling, laser cutting, injection molding, hydrophilic coating, and adhesive bonding, all relevant to the manufacturing of medical devices such as catheters, sheaths, steerable catheters/sheaths, dilators, and guidewires.
• Strong mechanical background with a working knowledge of metals and plastics processing.
• Experience in training and mentoring engineers in problem-solving and process development tools.
• Working knowledge of relevant medical device regulations and guidance (e.g., ISO 13485).
• Ability to thrive in an inclusive, collaborative, fast-paced environment with minimal direction.

Asset skills:

• Previous experience in a disposable medical device manufacturing environment.
• Expertise in the design of catheters, dilators, needles, and guidewires.
• Experience with braiding and reflow processes.
• Expertise in polymer/metal component design and manufacturing, including part design, injection molding, reflow, bonding/welding, heat treatments, and casting.
• Proficiency in fixture and tooling design.
• Experience with automated work cell and equipment design.
• Strong background in mechanical mechanism design and analysis

Our Distinctive Edge

• Effortless commute: say goodbye to commuting challenges/hassles with our complimentary shuttles and subsidized transit options, making your journey to work a breeze.
• Work-life integration: Embrace a well-balanced work-life rhythm through our hybrid model and flexible hours, empowering you to thrive both personally and professionally.
• Making a difference: Be a force for good with one dedicated day off for impactful volunteering, supporting causes close to your heart.
• Nurturing your career: Propel your career forward with abundant opportunities for on-site training, workshops, and personal development.
• Rewards that count: Reap the benefits of our comprehensive rewards package, including tuition reimbursement and a health spending account.
• Unleash your spirit: Join a thriving workplace culture filled with employee-led clubs, campaigns, sports teams, and exhilarating activities - fostering camaraderie and fun.

Our Impact

Baylis Medical Technologies is a leader in the development and manufacturing of innovative medical devices in the fields of radiology and cardiovascular. Headquartered in Canada, the company also provides contract manufacturing services to some of the world's leading medical device companies.

Baylis Medical Technologies is an equal opportunity employer and encourages applications from all qualified individuals.

Please inform us if you require any accommodations during the recruitment process.

Take the Leap

We are looking for talented individuals, like yourself, to join Baylis Medical Technologies and make a meaningful impact in the lives of patients. Be part of our mission to revolutionize patient care through cutting-edge technology and breakthrough solutions.

Are you ready to join us? Apply today and let's shape the future of healthcare together!

Want an inside look at careers and life at Baylis? See all our current job opportunities here and follow us on LinkedIn!

While we thank all applicants, only those being considered for an interview will be contacted.