Job Description

As a member of the Scientific Affairs team, the Product Engineer is responsible for design transfer activities of new products, and for supporting sustaining activities for existing products such product improvement implementation, supporting non-conformity investigations and mitigations, implementing material changes etc. You will act as a technical expert and provide mentorship to elevate the knowledge of those you work with.
The Product Engineer will also work with internal cross-departmental teams to identify process improvements and troubleshoot issue with both new and current production processes.
This will be a high energy role that will provide daily challenges.
HOW YOU WILL CONTRIBUTE

• Use your engineering knowledge and experience to support the design and development of medical devices, to ensure new products have manufacturability integrated into the design through good DFM and DFA practices.
• Act as a team lead by providing guidance and mentorship to other team members on good practices for design transfer, product and production documentation problem solving etc.
• Develop product and manufacturing specifications during product development to ensure the successful transfer of new designs to production
• Support and/or lead design transfer activities
• Work closely with cross-functional teams, acting as a key liaison with other departments particularly Engineering, Production, Supply Chain, and Quality
• Develop new processes for R&D use
• Scale up R&D processes to high volume production processes
• Develop and execute process validations plans, protocols and reports for equipment validations (IQ, OQ, PQ) and for end-to-end process validations (PV/ PPQ)
• Support the setup of contract manufacturers, working in partnership with them to develop new processes and manufacturing specification, and oversee their validations
• Support QC to set up acceptance criteria for new products and processes
• Implement Lean principals to reduce waste and increase quality
• Use Six Sigma methodology to analyse data to determine process performance and monitoring requirements
• Participate in risk management activities related to new or modified products or processes following ISO 14971
• Provide technical and complex information clearly to research personnel as well as to members of other departments including Production, Quality and Sales & Marketing

• Support research, planning and evaluation of alternate methods and testing procedures
• Support training of production personnel on new processes
• Use your expertise to improve internal processes where possible

WHAT YOU BRING

• Bachelor’s or Master’s degree in a life sciences or engineering discipline, preferably in medical technology, biology or related field
• Minimum 4 years’ industry experience and a track record of working in a GLP, GMP, and/or similarly regulated work environment
• Knowledge of, or experience, with ISO 13485, ISO 9001
• Must have experience with design/tech transfer activities for medical devices, pharma or other highly related manufacturing processes
• Must have process validation experience using industry standard methods for IQ, OQ and PQ
• Knowledge of statistical analysis for testing and process validation
• Excellent interpersonal skills, oral communication skills, and written communication skills

• Must be able to work independently following a brief period of specific technical training

• Must have strong analytical and technical writing skills
• Excellent computer skills (MS Office, Access, Excel)
• Organized and detail-oriented
• Ability to multitask and handle changing prioritize
  

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 kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share table

ABOUT BIOLYTICAL
bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid in-vitro medical diagnostics using its proprietary INSTI® technology platform. bioLytical has won several local and industry awards, including BC Exporter of the Year in 2019. We have been named Lifesciences BC’s Growth Stage Med Tech Company of the Year and have been featured on BC’s Fastest Growing Companies four years in a row, including the Globe and Mail’s Fastest Growing Companies list in 2020. bioLytical moved to a significantly larger, state-of-the-art facility in Richmond in 2020 to accommodate the extraordinary growth achieved through our team.
INSTI’S CORE VALUES

• INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes the initiative on projects.
• NEVER SAY NEVER: Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.
• SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.
• TAKES OWNERSHIP of goals, decisions, actions, and results: Arrives on time and prepared, leads by example, follows through on commitments.
• INSPIRED to excel: Demonstrates a passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business.

#science #research #researchanddevelopment #IVD #in-vitro #diagnostics #designtransfer #engineering