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Medical Device Manufacturing Jobs in Colorado (NOW HIRING)

Medium

Director of Operations - Medical Device

Golden, CO · On-site

$100 - $145/hr

... medical device environment. This role serves as the central point of accountability for program ... Partner with Manufacturing Engineering and Operations leadership to optimize production processes ...

Fusion Life Sciences

Quality Inspector

Englewood, CO · On-site

Temporary Contract Job Summary We are seeking a Quality Inspector I to join our Quality Lab team supporting medical device manufacturing. The Quality Inspector will be responsible for inspecting ...

Three Point Solutions

Sr Process Engineer

Boulder, CO · On-site

$45 - $50/hr

Medical Device Manufacturing Company Duration: 2 Years (Possible Extension) Location: Boulder, CO 80301 Shift: 1st Shift Job Summary * Provide engineering support for electron beam manufacturing ...

LivaNova

Medical Device Assembler

Arvada, CO

$19.50 - $21/hr

... and/or operating manufacturing equipment. You will follow existing policies, practices, and ... medical devices. We hire individuals who are looking for more than just a job. Every role at our ...

LivaNova, PLC

Medical Device Assembler

Arvada, CO · On-site

$19.50 - $21/hr

... and/or operating manufacturing equipment. You will follow existing policies, practices, and ... medical devices. We hire individuals who are looking for more than just a job. Every role at our ...

Three Point Solutions

Test Technician

Lafayette, CO · On-site

$30 - $35/hr

Medical Device Manufacturing Industry Location: Lafayette, CO 80026 Duration: 12 Months (Possible Extension) Shift: 1st Shift Key Responsibilities * Set up test equipment, fixtures, and test ...

Three Point Solutions

Design Technician

Lafayette, CO · On-site

$30 - $35/hr

Medical Device Manufacturing Industry Duration : 24 Months (Possible Extension) Location : Lafayette, CO 80026 Shift : 1st Shift Description: * Design and modify electronic components and systems.

Three Point Solutions

Design Technician

Lafayette, CO · On-site

$39 - $45/hr

Medical Device Manufacturing Company Location: Lafayette, CO 80026 Duration: 1 Year (Possible extension) Shift: 1st Shift Job Summary Experienced Design Technician focused on 3D CAD design ...

Three Point Solutions

Graphic Designer

Lafayette, CO · On-site

$40 - $45/hr

Medical Device Manufacturing Company Location: Lafayette, CO 80026 Duration: 6 Months Shift: 1st Shift Key Responsibilities * Create, format, and publish Instructions for Use (IFU) documents

Injectech LLC

Process Engineer

Fort Collins, CO

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related field. * 1+ years of experience in Injection Molding processes required, preferably in the medical device ...

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Medical Device Manufacturing information

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How much do medical device manufacturing jobs pay per hour?

As of Aug 13, 2026, the average hourly pay for medical device manufacturing in Colorado is $28.52, according to ZipRecruiter salary data. Most workers in this role earn between $24.28 and $33.37 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in medical device manufacturing?

To thrive in Medical Device Manufacturing, you need strong attention to detail, knowledge of quality assurance processes, and an understanding of regulatory standards such as ISO 13485 or FDA requirements. Experience with manufacturing equipment, ERP systems, and specialized tools for assembly and testing is typically required, and certification in areas like Six Sigma or Lean Manufacturing can be advantageous. Effective communication, teamwork, and problem-solving skills help individuals excel in fast-paced, multidisciplinary environments. These skills are vital for maintaining product safety, ensuring regulatory compliance, and meeting production targets in the highly regulated medical device industry.

Is medical device manufacturing a good job?

Medical device manufacturing is considered a stable and growing field with opportunities for skilled workers, including roles in assembly, quality control, and engineering. It often requires attention to detail, technical skills, and adherence to safety and regulatory standards, with potential for career advancement and competitive wages.

What career advancement opportunities are available in medical device manufacturing?

Medical Device Manufacturing offers a variety of career advancement paths, allowing employees to move into roles such as production supervisor, quality assurance specialist, or process engineer as they gain experience. Many companies provide on-the-job training, mentorship programs, and support for additional certifications to help employees further develop their technical and leadership skills. Team members who demonstrate strong performance and a commitment to continuous improvement may also transition into management positions or cross-functional roles in research and development, regulatory affairs, or supply chain management. This field values both specialized technical expertise and a proactive approach to professional growth, providing long-term career stability and diverse opportunities.

What is a medical device manufacturing job?

A Medical Device Manufacturing job involves producing, assembling, and testing medical devices to ensure they meet regulatory and quality standards. Workers in this field may operate machinery, inspect products, and follow strict guidelines to maintain safety and efficiency. Roles can range from machine operators and quality control inspectors to engineers and regulatory compliance specialists. This industry is essential for creating devices like surgical instruments, pacemakers, and diagnostic equipment used in healthcare. Attention to detail, adherence to regulations, and technical skills are key for success in this field.

What are popular job titles related to Medical Device Manufacturing jobs in Colorado? For Medical Device Manufacturing jobs in Colorado, the most frequently searched job titles are:
What job categories do people searching Medical Device Manufacturing jobs in Colorado look for? The top searched job categories for Medical Device Manufacturing jobs in Colorado are:
What cities in Colorado are hiring for Medical Device Manufacturing jobs? Cities in Colorado with the most Medical Device Manufacturing job openings:
Medical Device Manufacturing jobs near you
Infographic showing various Medical Device Manufacturing job openings in Colorado as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, and 5% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $59,318 per year, or $28.5 per hour.

Director of Operations - Medical Device

Biointellisense

Golden, CO • On-site

$100K - $145K/yr

Full-time

Posted 28 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 hr@biointellisense.com 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).
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.