Senior Process Engineer

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.

• 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.

• 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:
  • Solid Works, Catia or comparable CAD applications.
  • Minitab or comparable statistics applications.
  • Python / Jupyter or comparable data-handling and visualization applications.

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.
• Y…