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Executive Medical Device Jobs in Colorado (NOW HIRING)

HIGHRIDGE Inc.

Engineering Project Manager

Westminster, CO · On-site

$90 - $110/hr

Strong working knowledge of medical device product development, including design control, risk ... executives, and external partners.** ** · Strong organizational skills with the ability to manage ...

MIMEDX Careers

Account Executive - Denver, CO

Denver, CO · On-site

$84 - $102/hr

We are excited to add an Account Executive to our sales team! The position will pay between $84,000 ... Prefer 3-4 years of experience in the medical device, biotechnology, and tissue segments of the ...

Mimedx

Account Executive - Denver, CO

Denver, CO · On-site

$84 - $102/hr

We are excited to add an Account Executive to our sales team! The position will pay between $84,000 ... Prefer 3-4 years of experience in the medical device, biotechnology, and tissue segments of the ...

MiMedx Group

Account Executive - Denver, CO

Denver, CO · On-site

$84K - $102K/yr

We are excited to add an Account Executive to our sales team! The position will pay between $84,000 ... Prefer 3-4 years of experience in the medical device, biotechnology, and tissue segments of the ...

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All JobsMedical Device JobsExecutive Medical Device JobsExecutive Medical Device Jobs in Colorado

Executive Medical Device information

What is an executive medical device professional?

An Executive Medical Device professional is a senior leader responsible for overseeing the strategy, operations, and growth of a medical device company or division. They often manage teams, ensure regulatory compliance, drive product development, and foster relationships with stakeholders such as healthcare providers and regulatory agencies. Their role is crucial in navigating the complex healthcare landscape and ensuring that medical devices are safe, effective, and reach the market successfully.

What are the key skills and qualifications needed to thrive as an executive in the medical device industry?

To thrive as an Executive in the Medical Device industry, you need a strong background in business management, regulatory compliance, and healthcare technology, often supported by degrees in life sciences, engineering, or business administration. Familiarity with FDA regulations, quality management systems (such as ISO 13485), and product lifecycle management tools is typically required. Outstanding leadership, strategic thinking, and effective communication are crucial soft skills for guiding teams and fostering partnerships. These competencies ensure regulatory adherence, drive innovation, and position the company for sustained growth in a competitive market.

What are some typical challenges faced by an executive in the medical device industry, and how can they be addressed?

Executives in the medical device sector often navigate challenges such as strict regulatory compliance, rapidly evolving technology, and intense market competition. Balancing innovation with adherence to FDA or international standards requires strong cross-functional collaboration between R&D, regulatory affairs, and quality assurance teams. Building effective communication channels and fostering a culture of continuous learning can help address these challenges. Additionally, staying informed about industry trends and fostering strategic partnerships are crucial for long-term success.

What is the difference between Executive Medical Device vs Medical Device Engineer?

AspectExecutive Medical DeviceMedical Device Engineer
Required CredentialsTypically requires advanced degrees (MBA, MD) and leadership experienceBachelor's or Master's in Engineering, Biomedical Engineering, or related fields
Work EnvironmentCorporate leadership, strategic planning, executive meetingsDesign, development, testing, and manufacturing of medical devices
Employer & Industry UsageMedical device companies, healthcare organizations, regulatory agenciesMedical device manufacturing firms, R&D departments, biotech companies
Common Search & Comparison IntentUnderstanding leadership roles in medical device industryTechnical engineering roles in medical device development

Executive Medical Device professionals focus on strategic leadership, business development, and regulatory compliance, often requiring advanced degrees and management experience. Medical Device Engineers concentrate on designing, testing, and improving medical devices, with technical engineering credentials. Both roles are vital in the medical device industry but serve different functions within organizations.

What are the most commonly searched types of Medical Device jobs in Colorado?

The most popular types of Medical Device jobs in Colorado are:

What are popular job titles related to Executive Medical Device jobs in Colorado?

For Executive Medical Device jobs in Colorado, the most frequently searched job titles are:

What job categories do people searching Executive Medical Device jobs in Colorado look for?

The top searched job categories for Executive Medical Device jobs in Colorado are:

What cities in Colorado are hiring for Executive Medical Device jobs?

Cities in Colorado with the most Executive Medical Device job openings:

Executive Medical Device jobs near you
Infographic showing various Executive Medical Device job openings in Colorado as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 88% Physical, 1% Hybrid, and 11% Remote job distribution.

Director of Operations - Medical Device

Biointellisense

Golden, CO • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 23 days ago

Job description

Beware of recruiting scams. BioIntelliSense only contacts candidates from @biointellisense.com email addresses. We never conduct interviews over text, email or chat apps. If you receive a message that doesn't match this, treat it as fraudulent and email [email protected] to verify.
 
About BioIntelliSense
The future of healthcare is here. Join us to shape the future of healthcare for patients and clinicians. BioIntelliSense is helping to decode human physiology and pioneer a new standard of proactive monitoring to improve healthcare outcomes and save lives.  
 
Our FDA-cleared and award-winning BioButton wearables, BioHub gateways, BioMobile applications, BioCloud data services and the BioDashboard clinical intelligence system creates a comprehensive tech-enhanced solution that makes continuous monitoring reliable and scalable. Through our physiologic intelligence and AI-driven analytics, clinicians have access to vital sign trending and data-driven insights to enable earlier detection of patient health decline and proactive intervention for faster, safer care.
 
_______________________________________________________________________________________________________

About the Role

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 & Responsibilities
Operations & 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 Requirements
Education & 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
Company Culture and Benefits
 
Our Workplace Culture:
We're a dynamic remote-first environment, with offices in Golden, CO and Redwood City, CA and a talented, motivated team of colleagues globally. We're passionate about BioIntelliSense and are motivated by our shared mission. As OneBioTeam, we're a collaborative team that thrives in a fast-paced environment and embraces challenges as opportunities to shape the future, together. 
 
Comprehensive Benefits Package:
      Robust Medical, Dental and Vision Plans
      STD, LTD, Insurance Plans
      HSA and Flexible Spending Accounts
      Safe Harbor 401(k) Plan with 3% Employer Contribution with immediate vesting
      FlexVTO (flexible vacation plans), Paid Sick Leave, 11 Company Holidays
      Home Office Benefits Stipend for Fully Remote Roles
 
BioIntelliSense is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran, disability status or any other status protected under federal, state or local law.
Lever may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools may assist our recruitment team but do not replace human judgment. All final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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