The Manufacturing Technicianis responsible for performing precision assembly, processing, and inspection of Class II & III medical devices in a highly regulated environment. This role ensures products are manufactured in accordance with approved procedures, quality standards, and regulatory requirements, contributing directly to the delivery of safe and effective medical devices.

Production & Assembly

• Perform assembly, processing, and packaging of medical devices following detailed work instructions and SOPs
• Execute tasks requiring precision, attention to detail, and fine motor skills
• Operate manufacturing equipment and tools in accordance with established procedures
• Meet production targets while maintaining strict quality standards

Quality & Compliance

• Follow FDA regulations, ISO 13485 standards, and Good Manufacturing Practices (GMP)
• Complete accurate documentation in accordance with Good Documentation Practices (GDP)
• Perform in-process inspections and identify nonconformances
• Escalate quality or safety concerns to leadership as appropriate

Team & Operational Support

• Collaborate with team members and cross-functional partners to support production goals
• Participate in training, cross-training, and continuous learning initiatives
• Maintain a clean, organized, and compliant work environment
• Support process improvements and lean manufacturing activities

Process Development & Optimization

• Support process transfer from development through validation and commercialization for Class II & III medical devices
• Support development, characterization, and optimization of balloon catheter and steerable sheath manufacturing processes including braiding, reflow, thermal bonding, adhesive bonding, and handle assembly operations
• Drive manufacturing improvements focused on efficiency, reliability, and reduction of manual variability
• Support root cause investigations, and continuous improvement initiatives
• Apply problem-solving methodologies to resolve technical issues
• Participate in risk management activities in accordance with ISO 14971 and FDA quality system requirements

Validation & Compliance

• Contribute to validation activities including IQ, OQ, PQ, TMV, and IMV
• Support engineering in development of protocols, reports, and technical documentation in accordance with GMP and regulatory requirements
• Create and maintain work instructions and related engineering documentation
• Support equipment qualification, calibration activities, and test method validation efforts
• Partner with Quality and Manufacturing teams to maintain compliance with ISO 13485 and FDA Quality System Regulations

Key Competencies

• Attention to detail and quality-focused mindset
• Strong manual dexterity and hand-eye coordination
• Ability to work both independently and as part of a team
• Reliability and accountability in meeting production expectations
• Willingness to learn and adapt in a fast-paced environment

Skills, Knowledge, Experience & Qualifications

Required

• High school diploma or equivalent
• 3+ years of experience in manufacturing, assembly, or production (medical device preferred)
• Strong attention to detail and ability to follow written procedures exactly
• Ability to work in a regulated environment

Preferred

• Experience in Class II or III medical device manufacturing
• Background in precision assembly or catheter assembly,balloons or braided shafts
• Familiarity with GMP, FDA, and ISO standards
• Previous cleanroom experience

Physical Requirements

• Excellent fine motor skills and hand-eye coordination required
• Ability to stand or sit for extended periods of time, often for the majority of the work shift.
• Ability to perform repetitive hand and finger movements requiringhigh levels of dexterity and precision.
• Ability to lift and move materials up to 25 pounds (or another weight appropriate for your environment).
• Ability to maintain steady hand control for delicate work involving small components or biological materials.
• Ability to work under magnification, including frequent use of microscopes or magnifying equipment for extended periods.
• Ability to maintain sustained focus on detailed tasks in a production or laboratory environment.
• Ability to wear cleanroom gowning and PPE as required

Work Environment

• Work is performed in a controlled manufacturing and/or cleanroom environment
• Requires strict adherence to GMP, FDA, and ISO standards
• Use of specialized tools, microscopes, or precision equipment may be required
• Collaborative, team-oriented environment with a focus on quality and compliance
• May require shift work or schedule flexibility depending on production needs

Compensation:

Target base salary range: $24 - $30 /hr, plus eligibility for an annual short-term incentive (STI) targeted at 5% of base salary and equity participation. Final compensation will be determined based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

What We Offer:

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Inclusive Team Environment - collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package, including salary, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.

Health and Wellness Offerings:

• Medical, Dental, and Vision Plans
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Equity Program
• Paid Holidays & Vacation
• Employee Assistance Program