Manufacturing Engineer I

Role details

Build a career that makes an impact. ----------------------------------------

At huMannity Medtec, you don't just build a career, you help change lives.

For over 40 years, we have been advancing life-enhancing medical technologies that address unmet healthcare needs. Our teams bring together engineering, science, and clinical expertise to transform bold ideas into solutions that can make a difference for patients around the world.

We believe meaningful work and a balanced life go hand in hand. That is why we offer a 9/80 schedule, giving our employees every other Friday off. That means 26 extra long weekends each year to recharge, spend time with family and friends, pursue hobbies, or simply enjoy more balance outside of work.

Why huMannity Medtec? Mission-driven work that impacts lives A 9/80 schedule with every other Friday off Collaborative teams solving complex challenges Opportunities to learn, grow, and make an impact Weekly team traditions, monthly lunches, and quarterly events that bring us together

Position Summary

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We are seeking a Manufacturing Engineer I to support the development, transfer, optimization, and production of implantable medical devices and systems. This role works closely with Manufacturing, R&D, Quality, Supply Chain, Program Management, and Facilities to ensure products and processes are efficient, scalable, and compliant with regulatory and quality requirements.

The Manufacturing Engineer I will contribute throughout the product lifecycle, from early-stage development and process design through validation, production support, and continuous improvement. Successful candidates are hands-on problem solvers who enjoy working in a cross-functional environment, improving manufacturing processes, and helping bring innovative medical technologies to patients.

Essential Duties and Responsibilities

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New Product Introduction (NPI) & Process Development

• Partner with R&D teams to support product development, design transfer, and manufacturing readiness activities.
• Develop, validate, and improve manufacturing processes for implantable medical devices and systems.
• Support process validation activities including IQ, OQ, and PQ protocols and reports.
• Develop and maintain manufacturing documentation including SOPs, work instructions, PFMEAs, and process specifications.
• Support product and process transfers to suppliers, contract manufacturers, and remote manufacturing sites.
• Evaluate and qualify new materials, equipment, tooling, and suppliers.

Manufacturing & Production Support

• Support manufacturing operations and production builds through hands-on engineering support.
• Troubleshoot manufacturing, equipment, and process-related issues using root cause analysis techniques.
• Assist with production planning, workflow optimization, and manufacturing efficiency improvements.
• Analyze production data and process metrics to identify opportunities for performance improvements.
• Support manufacturing teams in executing work orders, tracking build progress, and resolving obstacles.

Sustaining Engineering & Continuous Improvement

• Drive continuous improvement initiatives focused on quality, yield, reliability, and cost reduction.
• Support corrective and preventive actions (CAPA) related to manufacturing processes and equipment.
• Optimize manufacturing layouts, workflow, resource utilization, and equipment performance.
• Support preventative maintenance activities and equipment reliability programs.
• Design, develop, and implement tooling, fixtures, and manufacturing solutions to improve productivity.

Quality & Compliance

• Ensure compliance with Good Manufacturing Practices (GMP), ISO 13485, FDA Quality System Regulations, and company procedures.
• Support internal and external audits by preparing documentation and representing manufacturing engineering activities.
• Participate in risk management, process control, and quality improvement initiatives.
• Collaborate with Quality Assurance and Supply Chain teams to support compliant manufacturing operations.

Required Qualifications

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• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Materials Engineering, or a related engineering discipline.
• 1+ years of engineering experience through industry experience, internships, co-ops, or equivalent hands-on experience.
• Experience supporting manufacturing processes, process improvement initiatives, or product development activities.
• Ability to read and interpret engineering drawings and CAD models.
• Experience using SolidWorks, AutoCAD, or similar CAD software.
• Understanding of process validation, risk management, and manufacturing documentation practices.
• Proficiency with Microsoft Office applications including Excel, Word, PowerPoint, and Outlook.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent written and verbal communication skills.
• Highly organized, self-motivated team player with strong attention to detail.

Preferred Qualifications

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• Experience within the medical device industry or another highly regulated manufacturing environment.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971, and GMP requirements.
• Experience supporting process validation activities including IQ/OQ/PQ.
• Familiarity with PFMEA, risk management, and statistical analysis tools such as Minitab or JMP.
• Experience supporting New Product Introduction (NPI) programs.
• Familiarity with cleanroom manufacturing environments.
• Lean Six Sigma certification or continuous improvement training.
• Experience supporting product and process transfers between manufacturing sites or suppliers.

Nice to Have

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• Experience with implantable medical devices and implantable materials.
• Hands-on experience with precision manufacturing processes including micro-machining, laser processing, welding, brazing, wire bonding, soldering, molding, or surface finishing.
• Experience with medical-grade polymers, silicones, adhesives, ceramics, titanium, platinum, or similar implantable materials.
• Familiarity with hermetic systems, electrical testing, automation, or high-volume manufacturing environments.

Work Environment

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• Office, laboratory, and manufacturing-based engineering environment.
• Frequent collaboration with Manufacturing, Quality, R&D, Supply Chain, and Program Management teams.
• Fast-paced environment supporting multiple projects and manufacturing activities.

Physical Requirements

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• Ability to remain in a stationary position while working at a computer and engineering workstation for extended periods.
• Ability to occasionally move throughout office, laboratory, and manufacturing environments.
• Ability to inspect components, equipment, and manufacturing processes.
• Ability to communicate effectively with team members and stakeholders.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.