Biointellisense

Wearable remote patient monitoring with analytics

Manufacturing Engineer - Medical Device

Manufacturing EngineeringConfirmed live in the last 24 hours

Full-timeGolden, CO, USA$80k - $120k /yr

About the Job

Requirements

A bachelor's degree in Mechanical, Electrical, Biomedical, Manufacturing, Industrial, or a related engineering discipline is required.
Three to eight years of experience in a manufacturing or industrial engineering environment with offsite or offshore manufacturing partners is required.
Medical device manufacturing experience working within a quality management system, such as ISO 13485 or FDA 21 CFR Part 820, is required.
Experience verifying and validating medical devices, software/tools, and systems is required.
Ability to perform root cause analysis is required.
Knowledge of manufacturing processes, fabrication methods, tool design, and quality assurance techniques is required.
Familiarity with manufacturing equipment and quality assurance techniques is required.

Responsibilities

Lead continuous improvement initiatives to enhance manufacturing efficiency through the development and optimization of tools, processes, and software.
Support manufacturing line setup and optimization at contract manufacturing partners, including line balancing, cycle-time reduction, and continuous improvement initiatives to increase production efficiency and throughput.
Support make-versus-buy evaluations and, when transitioning manufacturing or packout in-house, help develop and execute the transition plan, including process validation, equipment and resource requirements, and production readiness.
Manage verifications and validations of new product, device, and tool releases.
Generate protocols and standard operating procedures for final testing, handling, and reporting.
Support research and development systems testing.
Conduct systems and software validation.
Support root cause investigations.
Act as the main liaison between Operations, Research and Development, Product, Regulatory and Quality teams, and external manufacturing partners.
Ensure manufacturing processes and quality criteria meet company standards and that procedures comply with safety and environmental regulations.
Develop and test effective automated and manual systems.
Organize and manage manufacturing workflows and resources.
Collaborate with other engineers, contractors, and suppliers.

Desired Qualifications

A master's degree in engineering or an MBA is preferred.
Demonstrated experience building software tools to drive Lean or efficiency improvements, such as Python, SQL, Power BI, or Power Apps, from defining requirements through deployment and user adoption.
Experience mentoring or training interns, junior engineers, or technicians.
Lean Six Sigma Green Belt or Black Belt certification.
Experience with electronics/printed circuit board assembly or high-volume electronics assembly.
Experience integrating tools with manufacturing execution system or enterprise resource planning systems or manufacturing test data, and validating software used in production.
Ability to travel domestically and internationally to manufacturing partners.

Salary Range: 80000 to 120000 (Currency: USD) (Pay period: per-year-salary)

⚠️ 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.

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About The Role

We are looking for a Manufacturing Engineer to manage verifications and validations of our devices and software tools. This role will also collaborate internally with cross functional teams and externally with our manufacturing partners to ensure compliance, quality, and efficiency in our manufacturing process, engineering documentation and drawings, design transfers, etc.

We are open to this role being at the Engineer or Lead level based on experience.

What You'll Be Doing

Lead continuous improvement initiatives to enhance manufacturing efficiency through the development and optimization of tools, processes, and software
Support manufacturing line setup and optimization at contract manufacturing (CM) partners, including line balancing, cycle-time reduction, and continuous improvement initiatives to increase production efficiency and throughput
Support make-versus-buy evaluations and, when transitioning manufacturing or packout in-house, help develop and execute the transition plan, including process validation, equipment and resource requirements, and production readiness
Manage verifications and validations of new products/devices/tools releases
Generate protocols and SOPs for final testing, handling, and reporting
Support R&D systems testing
Conduct systems and software validation
Support root cause investigations
Act as the main liaison between Operations, R&D, Product and Regulatory / Quality teams and our external manufacturing partners
Ensure manufacturing processes and quality criteria meet BioIntelliSense’s standards and that procedures comply with safety and environmental regulations
Develop and test effective automated and manual systems
Organize and manage manufacturing workflows and resources
Collaborate with other engineers, contractors, and suppliers

What We Are Looking For

Bachelor’s degree in Mechanical, Electrical, BioMedical, Manufacturing, Industrial, or a related engineering discipline
3-8 years’ experience in a Manufacturing or Industrial engineering environment with offsite/offshore manufacturing partners
Medical device manufacturing experience working within a quality management system (ISO 13485, FDA 21 CFR Part 820)
Experience with verification and validations of medical devices, software/tools, and systems
Proven ability to perform root cause analysis
Excellent communication and project management skills
Knowledge of manufacturing processes, fabrication methods, tool design and quality assurance techniques
Familiarity with manufacturing equipment and quality assurance technique

Preferred Qualifications

Master’s degree in Engineering or an MBA

Demonstrated experience building software tools to drive Lean or efficiency improvements (e.g., Python, SQL, Power BI, Power Apps, or similar), from defining requirements through deployment and user adoption

Experience mentoring or training interns, junior engineers, or technicians

Lean Six Sigma Green Belt or Black Belt

Experience with electronics/PCBA or high-volume electronics assembly

Experience integrating tools with MES/ERP systems or manufacturing test data, and validating software used in production

Ability to travel domestically and internationally to manufacturing partners

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.

About the Company

Biointellisense

Wearable remote patient monitoring with analytics

BioIntelliSense offers remote patient monitoring through its BioButton wearable that continuously collects medical-grade vital signs for at-home use, with data fed to analytics for early-warning insights. Customers are hospitals, health systems, providers, and payors in the U.S. and select global markets, who buy the devices and analytics services to guide care and reduce hospital stays and emergencies. It differentiates itself by combining ease of use, comfort, and a cost-effective, continuous monitoring approach along with strategic healthcare partnerships (e.g., Ardent Health Services) and industry recognition. Its goal is to improve patient outcomes and lower healthcare costs by enabling proactive, at-home monitoring.

Company size: 51-200
Company stage: Series B
Total funding: $82M
Headquarters: Golden, CO
Founded: 2018

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