The Director of Operations is responsible for leading and coordinating cross-functional programs that drive on-time, on-budget execution of manufacturing and operations initiatives in a regulated medical device environment. This role serves as the central point of accountability for program planning, risk management, and execution across Manufacturing, Quality, Supply Chain, R&D, and Regulatory Affairs.
The successful candidate will balance strategic program ownership with hands-on tactical execution to support new product introductions (NPI), sustaining engineering changes, capacity expansion, and continuous improvement initiatives for Class II medical devices.
Job Description & ResponsibilitiesOperations & Manufacturing- Partner with Manufacturing Engineering and Operations leadership to optimize production processes, capacity, and throughput.
- Support process validations (IQ/OQ/PQ), equipment qualification, and production line readiness for new and existing products.
- Drive continuous improvement using Lean Manufacturing, Six Sigma, Kaizen, and Value Stream Mapping methodologies.
- Coordinate with Supply Chain to ensure material availability, supplier readiness, and inventory targets aligned with program plans.
- Lead operational readiness reviews and production hand-off activities from development to commercial manufacturing.
- Onsite warehouse employee oversight.
Quality & Regulatory Compliance- Ensure all program activities comply with FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485, and applicable EU MDR requirements.
- Support Design Transfer, Design Controls, and Design History File (DHF) deliverables in coordination with R&D and Quality.
- Drive engineering change orders (ECOs), CAPAs, and nonconformance resolutions through to closure with operational impact assessments.
- Partner with Regulatory Affairs to ensure program plans align with 510(k) submission timelines, post-market surveillance, and labeling requirements for Class II devices.
- Support internal, supplier, and external audits (FDA, Notified Body) as the Operations program lead.
Leadership & Communication- Facilitate cross-functional core team meetings, steering committee reviews, and executive program updates.
- Influence without direct authority across engineering, quality, supply chain, and external partners.
- Translate technical and regulatory complexity into clear, actionable communication for both technical teams and senior leadership.
- Mentor junior team members and contribute to building program management best practices and tools across the organization.
Job RequirementsEducation & Experience- Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Electrical), Operations Management, Supply Chain, or related technical discipline.
- 6-9 years of progressive experience in program management, project management, or operations within the medical device industry.
- Demonstrated experience managing complex, cross-functional programs from initiation through commercialization.
- Hands-on experience supporting medical device manufacturing operations (assembly, packaging, sterilization, or similar).
- Proven track record of delivering programs on time, on scope, and on budget in a regulated environment.
Technical & Regulatory Knowledge- Working knowledge of medical device manufacturing processes, production transfer, and operational scale-up.
- Strong understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971 (Risk Management), and design control requirements for Class II medical devices.
- Familiarity with 510(k) submission processes and post-market regulatory obligations.
- Experience with engineering change control, document control systems (e.g., Greenlight Guru, Arena, Agile, MasterControl), and ERP/MRP systems (e.g., NetSuite, SAP, Oracle).
- Understanding of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
Skills & Competencies- Proficient in program management tools (MS Project, SmartSheet, Jira, Asana, or equivalent).
- Advanced proficiency in MS Office Suite (Excel, PowerPoint, Word, Outlook); experience with Power BI or Tableau is a plus.
- Strong analytical, problem-solving, and decision-making skills with a data-driven mindset.
- Excellent written and verbal communication skills, including the ability to present to executive leadership.
- Demonstrated ability to manage competing priorities and drive results in a fast-paced, matrixed environment.
- Strong organizational, time management, and attention-to-detail skills.
Work Environment & Physical Requirements- Ability to work in both office and warehouse environments.
- Occasional travel to supplier sites, contract manufacturers, or other company locations.
- Ability to lift up to 25 lbs and stand for extended periods when supporting production floor activities.
Nice to Haves- Master's degree in Engineering, Operations Management, MBA, or related field.
- PMP, PgMP, or equivalent program/project management certification.
- Lean Six Sigma certification (Green Belt or Black Belt).
- Experience with Class II medical devices.
- Experience supporting FDA inspections or Notified Body audits in a leadership capacity.
- Experience with international manufacturing, contract manufacturing, or global supply chain operations.
- Experience supporting EU MDR transitions or international regulatory submissions (Health Canada, PMDA, NMPA, ANVISA).
- Experience with electromechanical or software-enabled medical devices (SaMD/SiMD).
- Working knowledge of cybersecurity considerations for connected medical devices (IEC 62304, FDA cybersecurity guidance).
$100,000 - $145,000 a year
Salary Expectations: Listed comp is total compensation and is based on experience.
Work Location: Onsite - Golden, CO Office
