ZipRecruiter

Log In

1

Manager Biomedical Manufacturing Jobs in Colorado

Medium

Director of Operations - Medical Device

Golden, CO · On-site

$100 - $145/hr

... risk management, and execution across Manufacturing, Quality, Supply Chain, R&D, and Regulatory ... Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Electrical), Operations ...

Excelitas Technologies

Senior FP&A Analyst

Boulder, CO · On-site

$114K - $130K/yr

... biomedical, semiconductor, industrial, consumer products, scientific, security, defense and ... Additionally, you will interact with upper management, international and domestic accounting teams ...

Luxium Solutions

Customer Service Representative

Boulder, CO · On-site

$16.75 - $23/hr

... biomedical, semiconductor, industrial, consumer products, scientific, security, defense and ... They will perform order management in a complex, fast-paced, and diverse environment. This ...

Leiters Inc

Senior Quality Engineer

Englewood, CO · On-site

$95K - $121K/yr

Bachelor's degree in Biomedical Engineering, Quality Management, or a related technical field. * 5+ years of experience in quality engineering or quality assurance roles within a manufacturing or ...

previous page

Showing results 41-60

All JobsBiomedical Manufacturing JobsManager Biomedical Manufacturing JobsManager Biomedical Manufacturing Jobs in Colorado

Manager Biomedical Manufacturing information

What is the difference between Manager Biomedical Manufacturing vs Biomedical Engineer?

AspectManager Biomedical ManufacturingBiomedical Engineer
Required CredentialsBachelor's degree in biomedical engineering, manufacturing, or related field; often requires management experienceBachelor's or master's degree in biomedical engineering or related field
Work EnvironmentManufacturing facilities, overseeing production processesResearch labs, hospitals, or design offices, focusing on device development
Employer & Industry UsageMedical device manufacturing companies, biotech firmsMedical device companies, research institutions, healthcare organizations
Common Search & ComparisonOften compared for leadership roles in manufacturingCompared for technical development and design roles

The Manager Biomedical Manufacturing focuses on overseeing production processes, managing teams, and ensuring quality in manufacturing settings. In contrast, Biomedical Engineers are involved in designing, developing, and testing medical devices and equipment. While both roles require biomedical knowledge, the manager role emphasizes leadership and operations, whereas the engineer role emphasizes technical design and innovation.

What are the most commonly searched types of Biomedical Manufacturing jobs in Colorado? The most popular types of Biomedical Manufacturing jobs in Colorado are:
Manager Biomedical Manufacturing jobs near you

Director of Operations - Medical Device

Biointellisense

Golden, CO • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 26 days ago

Job description

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® multiparameter wearables, BioHub™ gateways, BioMobile™ downloadable 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 high-resolution vital sign trending and data-driven insights to enable earlier detection of patient deterioration and proactive intervention for better, safer care.
We're a remote-first, lean start-up environment and our global BioTeam colleagues are growth-oriented, collaborative and passionate about our mission and the future of BioIntelliSense. We thrive in a fast-paced environment and embrace challenges as opportunities to shape the future, together.
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. We're a collaborative and welcoming team who thrive in the fast-paced start-up environment and are eager to advance an excellent workplace together.
As One BioTeam, we set a high bar for ourselves and are focused on scaling our solutions and outperforming expectations.
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), Sick Leave, 11 Company Holidays
• Home Office Benefits Stipend
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.
We 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 assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Apply