Job Description

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

SUMMARY OF THE JOB:

We are seeking a highly experienced and motivated Medical Device R&D Technician Manager to lead our R&D technician teams focused on catheter development and testing. The ideal candidate will have a minimum of 10 years of experience in the medical device industry, particularly in catheter technology, and will excel in managing both project R&D technicians.

Responsibilities:

Team Management: Oversee R&D technicians to ensure efficient workflow and high-quality output.

Pilot Line Management: Coordinate with core team leads and management to establish and manage build sequences on the pilot line, ensuring all projects are executed on time and meet design specifications.

Equipment Maintenance: Ensure all R&D labs pilot line equipment are calibrated, properly installed (through the Installation Qualification process), properly documentation is managed in a equipment binder, and maintained according to a defined preventative maintenance schedule. Manage PM schedules for all equipment and ensure engineering has created PM documentation.

New Equipment Installation: Collaborate with the engineering team on the installation and commissioning of new equipment, ensuring that all installations meet operational standards through completion of IQ process.

Lab Organization: Maintain a well-organized lab environment, including comprehensive documentation of lab materials inventory (wipes, alcohol, PPE) and timely ordering of supplies as needed.

Material Management: Oversee the organization, inventory management, and reordering of R&D materials such as extrusions, mandrels, adhesives, and luer fittings.

Waste Disposal Management: Ensure compliance with disposal regulations for R&D materials, including alcohol waste and unused devices.

Lab Safety: Ensure material safety sheets of managed in MSDS binder and work with facility safety to ensure OSHA compliance within lab is met. Files safety incident reports in a timely manner.

Training Compliance: Ensure all technicians are current with corporate Standard Operating Procedures (SOP) training and facilitate ongoing training and development.

Qualifications:

• BA or AA is preferred
• Minimum of 10 years of experience in the medical device industry, with a strong focus on catheter production and development.
• Proven experience managing R&D teams and pilot line operations.
• Solid understanding of regulatory requirements and industry standards in medical device development.
• Strong organizational skills and attention to detail, with the ability to manage multiple tasks simultaneously.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams.

Job Tags

Similar Jobs