Director, Hardware and Systems Engineering (R&D)

Director, Hardware and Systems Engineering (R&D)

San Diego, CA, United States Are you a visionary R&D leader ready to make a global impact in diagnostics? Do you thrive on driving operational excellence, inspiring high-performing teams, and delivering innovative solutions for products that change lives? If so, we want you to join our mission! About the Role : As our Director, Hardware and Systems Engineering, you will lead our multidisciplinary engineering functions to build molecular diagnostics instruments and associated consumables. You will drive our Diagnostics division's strategy, execution, and people development across mechanical, electrical, systems engineering, and consumables. This is a leadership role requiring a proven level of technical expertise, ideally within Medical Device and Diagnostics space, and a successful cross-functional leader partnering with Assay Development, Software, Quality and Regulatory, Operations, Clinical, and Supply Chain for successful delivery of our products from early stages to commercialization. This is a fully onsite role based in San Diego, CA.

Key Responsibilities :

• Strategy and leadership + Set technical strategy and operating model for Mechanical, Electrical, Systems, and Consumables aligned with clinical performance and business goals. + Serve on Engineering Staff; drive portfolio planning, resourcing, risk management, and cross-functional alignment. + Establish, enforce, and continuously improve design controls and the product development lifecycle from concept through sustaining.
• Organization and people + Build and develop managers, tech leads, and subject-matter experts; foster an inclusive, high-performance culture. + Own headcount planning, recruiting, onboarding, performance management, and career development for a ~30-person team.
• Program delivery and systems ownership + Lead system architecture and requirements flowdown, interface control, traceability, and V&V planning across instrument, cartridge, and assay. + Ensure robust DFX (DFM / DFA / DFT / DFR), risk management (FMEA / FTA), configuration / BOM integrity, and smooth transfer to manufacturing (instrument CM and cartridge / reagent suppliers). + Drive NPI and sustaining engineering : reliability growth, cost / quality / yield improvements, and field issue resolution (FRACAS / CAPA).
• Cartridge and assay integration + Own strategy and execution for the single-use cartridge : materials selection, microfluidic architecture, injection molding, film / foil lamination, sealing, valves / vents, and reagent loading. + Ensure compatibility with assay chemistry and instrument interfaces (thermal, optical, pneumatic / fluidic, motion), contamination control, packaging, and shelf-life via real-time and accelerated stability. + Partner with Supply Chain / Quality on supplier qualification, SQAs, lot release criteria, CoA / traceability, and change control.
• Quality, compliance, and safety + Maintain audit-ready DHF, DMR / DHR, and compliance with applicable standards and regulations, including : + ISO 13485, FDA 21 CFR 820 design controls, ISO 14971 risk management, IEC 62366 usability, IEC 61010-1 / 2-081 safety, IEC 61326 EMC, RoHS / REACH. + IVD-specific requirements (e.g., IVDR technical documentation, CLSI performance evaluation methods, labeling per 21 CFR 809). + Oversee instrument / cartridge verification and validation (including wet bench), environmental / EMC / safety testing, reliability / HALT, and test lab readiness.
• Partners, vendors, and budget + Own budgets and capital planning; allocate resources across internal teams and external partners. + Select and manage CMs / ODMs, cartridge molders, film / adhesive / foil vendors, reagent manufacturers, and toolmakers; define SOWs, SLAs, and vendor quality metrics.
• Metrics and communication + Define and report KPIs : schedule adherence, V&V pass rates, first-pass yield (instrument and cartridge), reagent yield and stability / shelf-life, seal integrity / leak rates, field reliability / complaints per million tests, cost-per-test, and team engagement. + Communicate status, risks, and mitigations to executives and across the organization.

Required experience and qualifications + BS in Mechanical, Electrical, Systems, Biomedical, or related engineering field required; MS / PhD preferred. + 1015+ years delivering regulated electromechanical products; 5+ years leading managers in a multidisciplinary engineering organization. + Direct experience with molecular diagnostics or IVD instrumentation and associated consumables at scale (tooling, CMs, reagent manufacturing under ISO 13485). + Strong systems engineering expertise : requirements management and traceability, architecture, interface control, risk management (ISO 14971), and V&V of instrument + assay + cartridge. + Hands-on leadership for complex systems (e.g., fluidics / pneumatics, motion control, optics / fluorescence detection, thermal control / PCR, power electronics, EMC). + Proven track record in DFX, design transfer, and sustaining engineering with measurable improvements in yield, reliability, and cost. + Familiarity with standards / regulations listed above and audit readiness (FDA, ISO 13485, IVDR). + Proficiency with PLM and requirements / tools (e.g., Arena / Agile, SolidWorks, Altium, Jama / Polarion, Jira), statistical methods (DOE, SPC), and reliability engineering. + Excellent people leadership, communication, and stakeholder management; able to scale organizations and influence across functions.

Consumables (cartridge) engineering and manufacturing at scale + 5+ years leading design and scale-up of single-use microfluidic cartridges from prototype through pilot and high-volume manufacturing. + Materials and process expertise : + Polymers / films / laminates (e.g., COC / COP, PP, PC, PET, foil) and compatibility with assay chemistries; extractables / leachables mitigation. + High-cavitation and family mold tooling, moldflow analysis, tolerance stack-ups, warp / shrink control, and surface finish callouts. + Joining / sealing : ultrasonic / laser welding, heat staking, solvent bonding, heat / pressure sealing and adhesives; seal integrity and leak testing (e.g., burst / pressure / vacuum decay). + Surface treatments / coatings (e.g., plasma, corona, silanization, hydrophilic / hydrophobic coatings) to control wetting, capillary flow, and biofouling. + Reagent and fill / finish operations within the cartridge : + Aseptic handling, micro-dispense metrology, dry reagent deposition, lyophilized beads, blister pack integration, humidity / moisture control. + Cold-chain, barrier packaging (MVTR / OTR), pouching with desiccants / oxygen scavengers, nitrogen backfill, and UDI / labeling as applicable. + Stability and shelf-life : real-time / accelerated studies, Arrhenius modeling, acceptance criteria, and lot release testing. + Manufacturing readiness and quality : + Cleanroom production (ISO 7 / 8), contamination control, environmental monitoring, and GMP for reagents. + Process development and validation (IQ / OQ / PQ), PFMEA / Control Plans, MSA / Gage R&R, SPC with Cp / Cpk targets, yield improvement and FRACAS / CAPA. + Automation and in-line inspection (vision systems, leak / pressure tests), traceability (lot / serial), COA / COC management, and LIMS integration. + Supplier and partner management : + Selecting and qualifying molders, film / foil / adhesive vendors, reagent manufacturers, and toolmakers; executing SQAs, audits, SCARs, and PPAP or equivalent. + Cost-per-test modeling and should-cost analysis; driving VAVE and DFM / DFA to meet margin and reliability targets.

The annualized base salary range for this role is $198,700 to $353,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Why Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. If you have the right skills and experience, apply today!