Manufacturing Technician; Mechanical

The Manufacturing Technician is a senior hands-on role responsible for the assembly, testing, packaging, and troubleshooting of Class III medical devices in compliance with documented procedures, quality standards, and regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 14644).

In addition to performing complex assembly and inspection tasks, the Manufacturing Technician will:

• Set up, calibrate, and maintain manufacturing equipment.
• Perform in-process quality verification and troubleshooting.
• Support new product introduction and process validation.
• Mentor and train Product Builders / Operators in best practices.

This role requires strong technical skills, a quality-first mindset, and the ability to work independently under minimal supervision.

This hands-on role contributes to the advancement of BiVACOR's innovative cardiovascular technology, requiring precision and attention to detail.

KEY RESPONSIBILITIES

Manufacturing

• Perform complex assemblies, repairs, inspections, and/or test operations following detailed instructions.
• Proactively identifies and communicates quality issues and concerns
• Record information on approved documents
• Perform equipment setup, calibration, preventive maintenance, and minor repairs (as applicable)
• Conduct in-process functional tests and mechanical/electrical checks
• Troubleshoot assembly, equipment, and process issues to identify root causes and support implementation of corrective actions
• Support engineering teams with prototype builds, design verification, and process validation activities.

Quality Compliance

• Maintain training proficiency and certifications to remain in compliance
• Maintain compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Complete production records, batch documentation, and device history records accurately and in real-time.
• Immediately report deviations, non-conformances, or equipment malfunctions to supervisors.
• Assist in implementing corrective and preventive actions (CAPAs)
• Maintain a culture of quality and accountability throughout the operations organization.

Operational Excellence & Continuous Improvement

• Suggest process improvements to enhance efficiency, quality, and safety.
• Participate in training programs to maintain knowledge of current procedures and regulatory requirements.
• Collaborate effectively with production, quality, and engineering teams

Operations Support

• Perform operations support tasks as required, e.g., receiving, inventory handling, or shipping.

QUALIFICATIONS AND EXPERIENCE

• Exceptional attention to detail and commitment to product quality.
• Strong focus on safety, cleanliness, and regulatory compliance.
• Ability to work both independently and as part of a team.
• Self-motivated, able to work independently, and take initiative in problem-solving
• Good communication skills for effective collaboration and reporting.
• Strong manual dexterity and hand-eye coordination, patience and care in handling delicate components.
• Proficiency in communication and understanding of English, including reading work instructions to consistently build defect-free medical products

Qualifications

• Associate degree in Manufacturing Technology, Engineering, or related technical field, or equivalent experience.
• Minimum 3+ years of experience in manufacturing, assembly, or production—preferably in medical devices, pharmaceuticals, or other regulated industries.
• Demonstrated ability to follow detailed instructions and document work accurately.

Preferred

• Experience in Class III medical device assembly or other high-risk medical products.
• Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14644 standards.
• Familiarity with process validation, IQ/OQ/PQ documentation, and NPI (new product introduction)
• Prior use of microscopes, precision measurement tools, and test equipment.
• Experience working in a cleanroom environment.
• Experience with Lean Manufacturing and related principles, and working directly with the engineers to make continuous improvement changes.

Physical Requirements

• Sit and/or stand for extended periods of time as needed

• Fine motor skills for precise assembly tasks.

• Capability to lift and move up to 25 lbs when needed.

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