Principal Engineer (Mechanical / Electro-mech

DenMat Holdings, LLC•Lompoc, CA

13d•Onsite

About The Position

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.

Requirements

Bachelor's or Master's in Mechanical, Electro-mechanical, Mechatronic, or Electrical Engineering (or closely related discipline). PhD welcome but not required.
12+ years of progressive technical experience in mechanical or electro-mechanical engineering, preferably in medical device or another regulated industry. No prior people-management experience required — this is a senior individual contributor role.
Recognized subject-matter expertise in electro-mechanical assembly — e.g., motor and actuator sub-assemblies, sensor integration, harnessing, bonding/adhesive processes, ultrasonic welding, functional and end-of-line test.
Deep working knowledge of machine maintenance, calibration, and industrial automation — including PLCs, servo systems, pneumatics, vision systems, and reliability / preventive maintenance programs.
Demonstrated experience authoring and maintaining technical files and Design History Files per EU MDR 2017/745 Annex II and 21 CFR 820.30(j).
Strong working knowledge of process development, process excellence, and process validation (IQ/OQ/PQ) per ISO 13485:2016 §7.5.6 and 21 CFR 820.75 — including design of experiments (DoE), GR&R, statistical analysis, and engineering project management.
Demonstrated mastery of structured problem-solving methodologies — 8D, A3, DMAIC, 5 Whys, Ishikawa, FTA, and PFMEA / DFMEA — and a track record of leading complex multi-disciplinary investigations to closure.
Hands-on fluency with applied statistics for manufacturing: SPC, capability analysis (Cp/Cpk/Pp/Ppk), MSA / GR&R, hypothesis testing, regression, and DoE — ideally supported by tools such as Minitab or JMP.
Demonstrated experience leading CAPA investigations through to verified effectiveness per 21 CFR 820.100 and ISO 13485:2016 §8.5.2, with investigation reports that have withstood FDA inspection or Notified Body audit scrutiny.
Strong working command of Lean Manufacturing — VSM, standard work, 5S, SMED, kanban, line balancing, kaizen, poka-yoke — and Six Sigma at Green Belt or Black Belt level (certification preferred but not required).
Demonstrated track record of delivering quantified operational efficiency improvements (OEE, FPY, throughput, scrap, COPQ, labour productivity) on electro-mechanical assembly or comparable manufacturing operations.
Practical fluency with risk management per ISO 14971:2019 and its application to design changes, process changes, supplier changes, and CAPA actions.
Proven track record of driving complex technical projects from concept to validated production through influence and expertise rather than direct authority.
Demonstrated ability to mentor, coach, and grow other engineers — through design reviews, technical reviews, standards-setting, and on-the-job teaching.
Outstanding ability to influence without authority — building consensus across cross-functional and cross-site teams (Operations, Quality, Regulatory, R&D, Supply Chain).
Experience in establishing strong technical business cases for engineering projects in a manufacturing facility.
Results- and performance-driven with deep ownership of technical outcomes; proactive and self-directed.
Strong technical, analytical, and organizational skills.
Demonstrated ability to work within tight deadlines with proven experience in meeting goals in a timely manner.
Ability to deal with a variety of abstract and concrete variables.
Ability to work effectively with peers both internally and externally, including external equipment vendors and automation integrators.
Outstanding verbal and written communication skills, including the ability to convey complex technical concepts to non-technical audiences.
Excellent presentation and public speaking skills, including comfort presenting to senior management, customers, and regulators.
Excellent independent decision making, analysis, and problem-solving skills.
Understand and act on financial information that contributes to business profitability (e.g., make/buy analysis, ROI on capital and automation investments).
Ability to plan and lead successful engineering projects; understand available resources, develop timeline, budget, and identify task ownership across a cross-functional team.
Ability to lead engineering project teams to achieve company goals through technical leadership and influence rather than line management.
Excellent planning and organizational skills and techniques.
Communicate effectively with senior management.
Good negotiating skills and ability to support outsourced relationships, including contract manufacturers and equipment vendors.
Ability to influence, build relationships, understand organizational complexities, and manage conflict.
Broad professional and technical breadth with a strong understanding of industry practices and company policies and procedures.
Ability to operate effectively within virtual and geographically distributed engineering project teams.
Ability to mentor and develop other engineers without direct line authority.
Typically, 8 or more years of increasing technical responsibility and complexity in mechanical, electro-mechanical, or manufacturing engineering. People-management experience is not required.

Nice To Haves

Master's degree or global equivalent a plus.
PhD welcome.

Responsibilities

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.
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; ensure escalation to Quality and Regulatory Affairs where reportability under 21 CFR 803 (MDR) or EU MDR 2017/745 Article 87 (vigilance) may apply.
Author clear, defensible investigation reports suitable for FDA inspection, Notified Body audit, and internal QMS review; mentor other engineers in technical-writing standards for investigations.
Build problem-solving capability across the site engineering and technician population through hands-on coaching, structured kaizen events, and standardised templates.
Author and maintain technical files and Design History File content for site-manufactured product in line with EU MDR 2017/745 Annex II (Technical Documentation) and 21 CFR 820.30(j) (DHF), partnering with Quality and Regulatory Affairs as engineering technical owner.
Provide subject-matter expertise on machine maintenance, calibration, and industrial automation — covering PLC, servo, pneumatic, sensor, and vision systems — including reliability engineering, preventive maintenance strategy, and equipment requalification per ISO 13485:2016 §6.3 (Infrastructure) and §7.5.1(c).
Own the engineering contribution to the site's operational efficiency agenda — translating Plant strategic objectives into a prioritised, data-driven pipeline of efficiency projects with quantified business cases (yield, throughput, labour, scrap, energy, COPQ).
Drive Overall Equipment Effectiveness (OEE) improvement on electro-mechanical assembly lines by analysing the three OEE components (Availability, Performance, Quality) and targeting the loss categories with greatest financial impact.
Lead value stream mapping (VSM) of end-to-end manufacturing flows; identify and remove non-value-add activities, queues, and rework loops.
Apply Lean tools rigorously and coach others in their use: standard work, 5S, SMED (single-minute exchange of die / changeover reduction), kanban, line balancing (takt-based), kaizen events, A3 thinking, and visual management.
Apply Six Sigma DMAIC methodology to chronic process variation; deploy Statistical Process Control (SPC) on critical-to-quality (CTQ) parameters with appropriate control limits, Western Electric rules, and reaction plans.
Use Theory of Constraints (TOC) thinking to identify and elevate the system bottleneck; sequence improvement work so capacity gains are realised rather than absorbed upstream.
Drive First Pass Yield (FPY) and rolled throughput yield (RTY) improvement; design and implement poka-yoke (error-proofing) into assembly fixtures, work instructions, and test stations.
Lead targeted scrap and rework reduction campaigns; quantify and track Cost of Poor Quality (COPQ) including internal failure, external failure, appraisal, and prevention costs.
Drive cycle-time and changeover-time reduction on electro-mechanical assembly lines through workstation re-design, fixture improvements, and automation insertion.
Improve labour productivity through line re-balancing, work-content analysis, and targeted automation of low-skill / high-volume tasks (cobots, pick-and-place, automated test).
Improve maintenance efficiency through reliability-centred maintenance (RCM), MTBF/MTTR tracking, condition-based monitoring, and spare-parts strategy.
Identify and deliver utility and energy efficiency improvements (compressed air, HVAC, lighting, process heating) where these contribute meaningfully to site COGS or sustainability objectives.
Apply risk-based qualification thinking to validation work to avoid over-validating low-risk changes — using ISO 14971:2019 risk output to scope IQ/OQ/PQ effort proportionately and reduce time-to-implementation while remaining compliant with 21 CFR 820.75 and ISO 13485:2016 §7.5.6.
Embed change control discipline in all efficiency projects per 21 CFR 820.70(b) (Production and process changes) and ISO 13485:2016 §7.5.6, ensuring efficiency gains are validated, documented, and sustained — not lost to drift over time.
Track and report efficiency project outcomes against committed business cases; close the loop on benefits realisation and feed lessons learned back into the project pipeline.
Lead the technical execution of capital projects (CapEx) — equipment specification, supplier technical evaluation, installation, commissioning, and process validation (IQ/OQ/PQ) per 21 CFR 820.75 and ISO 13485:2016 §7.5.6.
Design and execute cost improvement (COGS reduction) initiatives, applying change control per 21 CFR 820.70(b) and ISO 13485:2016 §7.5.6.
Provide cross-functional technical leadership across manufacturing engineering, maintenance & facilities, technical projects, and NPI activities — without direct line-management responsibility.
Partner with R&D, customers, and commercial teams to define NPI requirements and translate them into manufacturable design inputs per 21 CFR 820.30(c) and ISO 13485:2016 §7.3.3.
Contribute to the development and implementation of the Company's strategic objectives by representing the engineering technical position in strategic discussions.
Establish and maintain engineering standards, design rules, and process specifications that affect the sub-function.
Champion compliance with EHS requirements, cGMP per 21 CFR 820, ISO 13485:2016, and the Company's Quality Policy through technical decisions and engineering judgment.
Mentor and coach junior and mid-level engineers and technicians; provide technical leadership through design review, code/spec review, and on-the-job teaching — without formal management authority.
Drive continuous improvement focus on Safety, Quality, Cost, and manufacturing efficiency through technical innovation and engineering rigor.