ObjectiveThis 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.
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; 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).
Operational Efficiency & Continuous Improvement:- 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.
SPECIFIC KNOWLEDGE & SKILLS:- 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.
GENERAL SKILLS & COMPETENCIES:- 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 rat
