Manufacturing Engineer (Medical Device)

⚠️ 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 Manufacturing Services Engineer will be the main liaison between our Operations team and our external manufacturing partners to ensure manufacturing needs and timelines at BioIntelliSense are met. 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.