ZipRecruiter

Log In

1

Director Biomedical Engineer Jobs in Colorado (NOW HIRING)

Actalent

R&d Engineer

Aurora, CO

$57.69/hr

Bachelor's or Master's degree in Mechanical, Biomedical, Electrical, or a related engineering field. * Experience in R&D within the medical device industry, with direct involvement in product design ...

Numotion

Rehab Technology Supplier

Windsor, CO

$45K - $70K/yr

... or biomedical engineering will be considered. * Minimum two (2) years' experience in Assistive Technology direct customer-related services or related field may be considered. * Must have valid ...

previous pagenext page

Showing results 21-40

All JobsBiomedical Engineer JobsDirector Biomedical Engineer JobsDirector Biomedical Engineer Jobs in Colorado

Director Biomedical Engineer information

See Colorado salary details

$13

$40

$70

How much do director biomedical engineer jobs pay per hour?

As of Aug 26, 2026, the average hourly pay for director biomedical engineer in Colorado is $40.70, according to ZipRecruiter salary data. Most workers in this role earn between $27.61 and $49.56 per hour, depending on experience, location, and employer.

What is a director biomedical engineer?

Director Biomedical Engineers are senior professionals who lead the biomedical engineering department within healthcare organizations, research institutions, or medical device companies. They oversee the development, implementation, and maintenance of biomedical equipment and ensure compliance with industry standards and regulations. In addition to managing teams and projects, they often collaborate with other departments, set strategic goals, and drive innovation in medical technology. Their role is crucial for maintaining high-quality patient care and advancing medical research and device development.

What are some typical challenges faced by a director biomedical engineer when managing cross-functional projects?

As a Director of Biomedical Engineering, one common challenge is aligning the goals and timelines of diverse teams such as clinical staff, engineers, and regulatory specialists. Effective communication and project management skills are crucial to ensure that everyone stays on track while adhering to safety and compliance standards. Additionally, balancing innovation with regulatory requirements and budget constraints often requires creative problem-solving and strong leadership. Successful directors foster collaboration and maintain open channels for feedback to navigate these complexities efficiently.

What are the key skills and qualifications needed to thrive as a director biomedical engineer, and why are they important?

To thrive as a Director Biomedical Engineer, you need advanced knowledge in biomedical engineering principles, leadership experience, and typically a master's or doctoral degree in biomedical engineering or a related field. Familiarity with regulatory standards (such as FDA or ISO), project management software, and medical device design tools is essential. Strong soft skills include strategic thinking, effective communication, and the ability to lead multidisciplinary teams. These skills are critical for overseeing complex projects, ensuring regulatory compliance, and driving innovation in biomedical technology.

What is the difference between Director Biomedical Engineer vs Biomedical Engineer?

AspectDirector Biomedical EngineerBiomedical Engineer
CredentialsBachelor's/Master's/PhD in biomedical engineering or related field; often requires leadership experienceBachelor's or Master's in biomedical engineering or related field
Work EnvironmentLeadership roles in hospitals, medical device companies, or research institutionsDesign, develop, and test medical devices in labs or manufacturing settings
ResponsibilitiesOversees projects, manages teams, strategic planningPerforms technical design, testing, and analysis

The main difference is that a Director Biomedical Engineer holds leadership and strategic responsibilities, overseeing teams and projects, while a Biomedical Engineer focuses on technical design and development tasks. Both roles require relevant education, but the director position emphasizes management experience and strategic planning.

What are the most commonly searched types of Biomedical Engineer jobs in Colorado?

The most popular types of Biomedical Engineer jobs in Colorado are:

What cities in Colorado are hiring for Director Biomedical Engineer jobs?

Cities in Colorado with the most Director Biomedical Engineer job openings:

Director Biomedical Engineer jobs near you

Director of Operations - Medical Device

Golden, CO

Biointellisense
51 - 200 employees
Learn more about Biointellisenseexternal

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 12 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.
apply for this job

Apply