Engineering Program Director

Engineering Program Director 18655 Madrone Parkway, Morgan Hill, CA 95037 Hybrid work $150,000

• $200,000 a year
• Full-time $150,000
• $200,000 a year
• Full-time # Engineering Program Director — Senior Staff PDV MedTech is seeking an Engineering Program Director to lead the engineering team through complex, multi-customer development and manufacturing programs across a global footprint.

This role sits at the intersection of engineering execution, customer engagement, and operational delivery, requiring both deep technical fluency and strong program leadership across distributed teams in the U.S., Europe, and India. The Director will provide technical mentorship, drive engineering excellence, and develop the engineering organization to enable consistent, high-quality delivery across programs. The ideal candidate thrives in a fast-paced CDMO environment, can lead an engineering team supporting multiple high-stakes programs at the same time, and brings a systems-level mindset to product realization from concept through commercialization. We describe ourself as a partner that supports customers from concept design to high-volume commercial production through capabilities that include product development, prototyping, injection molding, mold tool fabrication, 3D printing, cleanroom assembly, inspection, packaging, and ISO 13485-certified manufacturing. ## Position summary The Engineering Program Director is a member of the senior staff and serves as the senior leader responsible for engineering execution across multiple customer programs. This person combines technical depth, people leadership, and customer-facing program direction to guide engineering teams through development, validation, transfer, scale-up, and commercialization. This role requires proven experience taking a medical device or combination product from concept to commercialization, including design controls, verification, validation, manufacturing readiness, and launch planning. The successful candidate must also have direct experience authoring, co-authoring, or substantially supporting 510(k) submissions in partnership with regulatory and quality teams. ## Key responsibilities

• Lead multiple concurrent customer programs spanning design, development, validation, manufacturing transfer, and commercialization.
• Serve as the primary executive interface for customers, ensuring alignment on scope, timelines, risk, deliverables, and overall program health.
• Lead, manage, and mentor engineering teams, including senior engineers and program leaders, strengthening both technical capability and execution discipline.
• Drive cross-functional execution across engineering, quality, regulatory (external), supply chain, and operations teams in global locations.
• Establish and maintain integrated program plans, including resource allocation, milestones, dependency tracking, and critical path management.
• Identify and mitigate technical, operational, and regulatory risks proactively, serving as the escalation point for complex engineering challenges.
• Ensure programs meet design control requirements, regulatory standards, and customer expectations, with direct accountability for engineering quality.
• Coordinate design reviews, phase-gate reviews, and executive-level program updates.
• Develop and standardize program management and engineering processes to improve scalability, efficiency, and repeatability across the organization.
• Partner with business development and account management to support customer growth and long-term partnerships.
• Lead program financial performance, including budgeting, forecasting, margin management, and resource planning across the engineering organization. ## Technical scope This role requires hands-on familiarity with medical device development and manufacturing processes, along with the ability to guide, review, and mentor across the following areas:
• Product design and development, including mechanical systems, disposables, and electromechanical products.
• Design controls under FDA and

ISO 13485

requirements, including DHF management.

• Verification and validation, including IQ, OQ, and PQ.
• Process development and scale-up, including molding, assembly, and automation.
• Sterilization methods such as EtO, CD, gamma, and e-beam, along with associated validation planning.
• Supply chain development and supplier qualification.
• Risk management aligned with

ISO 14971.

• Transfer to manufacturing and sustaining engineering. ## Program execution requirements Successful program delivery at PDV requires strong capability in the following areas, with added emphasis on leadership and organizational impact:
• Multi-program management across diverse customers with competing priorities.
• Global team coordination across time zones and cultures.
• Clear communication structures, including regular cadence with customers and internal stakeholders.
• Robust documentation practices aligned with regulatory expectations.
• Rapid issue resolution and escalation management.
• Data-driven decision-making using program metrics and KPIs.
• Change management and configuration control discipline.
• Alignment of engineering outputs with manufacturing readiness and commercial timelines.
• Development of team capability in both technical execution and program management best practices. ## Qualifications
• Bachelor's or Master's degree in Engineering, including Mechanical, Biomedical, Manufacturing, Physics or a related field.
• 10+ years of experience in medical device development and or contract manufacturing.
• Proven experience managing multiple complex programs simultaneously.
• Demonstrated success leading global, cross-functional teams.
• Strong understanding of regulatory and quality systems in the medical device industry, including ISO 13485 and FDA design control requirements.
• Experience interfacing directly with customers in a CDMO or similar environment.
• Experience building or scaling engineering and program management processes and teams in a dynamic environment preferred.
• PMP or equivalent program management certification preferred.
• Direct experience taking a product from concept to commercialization.
• Direct experience supporting or authoring 510(k) submissions. ## Leadership profile
• Strong people leader with a demonstrated ability to build, mentor, and retain high-performing engineering teams.
• Highly organized with the ability to manage complexity without losing execution focus.
• Technically credible with engineering teams and trusted by customers.
• Comfortable operating at both strategic and tactical levels.
• Strong communicator with executive presence.
• Proactive, accountable, and results-driven.

## Why PDV MedTech PDV MedTech partners with medical device companies to bring products from concept to commercialization through a combination of engineering depth, in-house manufacturing capabilities, and a scalable operating model. The company states that it operates facilities in California, Utah, and Colorado, maintains

ISO 13485

2016 certification and FDA registration, and supports customers with cleanroom manufacturing and related commercialization services.

Pay:

$150,000.00

• $200,000.

00 per year

Benefits:

401(k) Dental insurance Employee assistance program Flexible schedule

Work Location:

Hybrid remote in Morgan Hill, CA 95037