Principal Engineer; Mechanical​/Electro-mech

Principal Engineer

This senior technical position within Henry Schein engineering is based on-site at the Lompoc, California manufacturing site and serves as the principal technical authority for mechanical and electro-mechanical engineering at the site. The role requires daily on-site presence (5 days per week) on the production floor and in the assembly area; it is not eligible for remote or hybrid working arrangements.

As a senior individual contributor — without direct people-management responsibility — the Principal Engineer provides deep technical leadership across day-to-day site operations, new product introduction (NPI), structured problem solving, technical file authorship, machine maintenance and automation, and continuous improvement. The role operates in a highly regulated medical device environment governed by 21 CFR 820, ISO 13485:2016, and EU MDR 2017/745.

Core areas include providing technical ownership of the electro-mechanical assembly area; leading complex problem solving and CAPA investigations; driving operational efficiency through structured Lean and Six Sigma programs; supporting machine maintenance, calibration, and industrial automation; and authoring and maintaining technical files in line with EU MDR 2017/745 Annex II. The Principal Engineer mentors and develops less-senior engineers and influences technical direction through expertise and engineering judgment rather than line management.

This is an exciting opportunity to join the Engineering team in Henry Schein at the Lompoc site as the company continues to expand its manufacturing capabilities across business units geographically located throughout North America and Europe.

Essential duties and responsibilities include the following. Other duties may be assigned.

• Serve as the senior technical authority for mechanical and electro-mechanical engineering at the site, setting technical direction, design rules, and engineering best practices.
• Provide technical ownership of the electro-mechanical assembly area and supports mixing processes — including process design, line layout, line balancing, work instructions, fixture/jig/tooling design, and ongoing process performance — in compliance with 21 CFR 820.70 (Production and process controls) and ISO 13485:2016 §7.5.1.
• Support day-to-day site activities by providing rapid, hands-on engineering response to complex production, quality, and supply issues across mechanical and electro-mechanical product lines.

Problem Solving & CAPA Leadership:

• Lead complex, multi-disciplinary technical investigations across the Lompoc site — from rapid floor-level triage of an assembly issue through full root-cause analysis of recurring or systemic failures.
• Apply and coach others in structured problem-solving methodologies appropriate to issue complexity: 8D, A3, DMAIC (Define / Measure / Analyse / Improve / Control), 5 Whys, Ishikawa (fishbone), Fault Tree Analysis (FTA), and Process / Design FMEA.
• Drive nonconformance handling and CAPA investigations per 21 CFR 820.90 (Nonconforming product), 21 CFR 820.100 (CAPA), ISO 13485:2016 §8.3 (Control of nonconforming product), and ISO 13485:2016 §8.5.2 (Corrective action) — including proper distinction between containment, correction, corrective action, and preventive action.
• Apply statistical methods to characterise process and product issues — including SPC trend analysis, capability studies (Cp, Cpk, Pp, Ppk), measurement system analysis (GR&R per AIAG MSA), hypothesis testing, and regression — to ensure conclusions are data-driven rather than anecdotal.
• Perform and document risk impact assessment on proposed problem-solving actions per ISO 14971:2019 §5 (Risk analysis) and §7 (Risk control) before implementation; ensure benefit-risk justification per ISO 14971:2019 §8 where residual risk increases.
• Define, execute, and document effectiveness verification (EV) for corrective actions per 21 CFR 820.100(a)(4) and ISO 13485:2016 §8.5.2(f), with quantitative acceptance criteria established up-front.
• Lead cross-functional 'rapid response' / containment teams when escalated issues threaten line output, on-time delivery to customers, or product quality;…