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Senior Process Engineer
Vital Bio
- Oakville, Manitoba, Canada
- Oakville, Manitoba, Canada
À propos
Location: Oakville, Ontario HQ
Compensation: $110,000 - $130,000 / year
Description
About You:
You are a Senior Process Engineer who thrives on turning complex medical product designs into reliable, high-throughput production. You love architecting and refining automated assembly processes, and you are data-driven in how you plan experiments, qualify equipment, and solve problems on the line. You balance big-picture systems thinking with a strong command of technical details, from process flows and risk analyses to IQ/OQ/PQ and CAPAs. You take ownership, communicate clearly, and collaborate closely with cross-functional teams and suppliers to keep quality high, costs in check, and capacity growing. You enjoy the pace and ambiguity of a startup environment and are energized by mentoring others as you help build scalable manufacturing for Vital's next-generation diagnostics.
What You'll Do:
Develop manufacturing processes (PFD, pFMEA) for high-throughput consumables assembly operations.
Create requirement specifications (URS) for associated automated production equipment.
Develop and conduct equipment qualifications for automated production equipment (IQ/OQ/PQ protocols, reports).
Serve as the primary sustaining engineering resource for high-volume assembly operations.
Execute continuous-improvement projects for cost reduction, capacity expansion, and issue resolution.
Liaise with suppliers for custom-component development; perform material qualification.
Serve as process owner for nonconformances, CAPAs, and associated root-cause investigations.
Mentor junior staff, including engineering co-op students.
What You'll Need:
Degree(s) in one or more related engineering discipline(s). Preference given to applicants with degree(s) in mechanical engineering, automation or mechatronics engineering, or chemical engineering.
B.S. with 7+ years' experience, or M.S. / M.Eng. / Ph.D. with 3+ years' experience, ideally in high-volume manufacturing operations or R&D roles in a medical device company.
Working knowledge of Quality Management System requirements for medical devices, specifically ISO 13485 and 21 CFR 820 quality system regulations.
Ability to multitask across projects and activities; strong communication skills and ability to present complex information succinctly (verbal, written, presentations).
High attention to detail and commitment to mastery of system-level knowledge of the products you are responsible for.
High sense of personal ownership of assignments; results-oriented; data driven.
Proven ability to collaborate cross-functionally and participate in multi-disciplinary teams.
Experience with statistical approaches to planning experimental work and analyzing resulting data (e.g., DOE, SPC, process capability, components-of-variance analysis).
Working familiarity with standard business systems (Google Suite, MS Office).
Bonus Points For:
Demonstrated history of successful application of DMADV / DMAIC / 6σ principles in developing and optimizing manufacturing processes.
Prior experience with:
Automated assembly of consumables comprising injection-molded plastic cartridges, wet and dry reagents, adhesives and films.
Automated filling and sealing of liquid-reagent vials.
Mechatronics – including controls, construction, debugging/optimization, automated vision, AI integration.
Developing or optimizing lyophilization processes.
High-volume injection molding of consumable components, validation of injection molding processes, qualification of molded components.
Facilities expansions and associated qualifications.
Capability with:
SolidWorks, Catia or comparable CAD applications.
Minitab or comparable statistics applications.
Python / Jupyter or comparable data-handling and visualization applications.
Why Join Us?
Vital Bio, you will:
Help build next-generation diagnostics from the ground up, owning manufacturing processes that directly influence product quality, reliability, and patient impact.
You'll work at the intersection of engineering, science, and operations, collaborating closely with cross-functional teams to turn ideas into scalable, automated production.
We move quickly, trust you with real responsibility, and give you the space to experiment, learn, and continuously improve how we build.
You'll grow alongside a team that values curiosity, clear communication, and thoughtful rigor—and that still makes time to enjoy the ride together.
Compensation will be determined based on the individual's demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.
This role is a current, onsite vacancy.
Compétences linguistiques
- English
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