Overview
Ontogen Manufacturing is seeking an experienced medical device assembler to join our team. The ideal candidate will possess experience in medical device manufacturing, including cleanroom assembly, with excellent documentation skills and attention to detail. The position will be responsible for executing documented assembly instructions for regulated medical devices, as well as ensuring that all cGMP requirements are observed.
Responsibilities
- Production of a wide array of medical devices in an FDA/ISO regulated environment (per 21 CFR 820, ISO 13485, and cGMP)
- Perform assembly operations inside of cleanroom and ESD-controlled environments
- Work safely with automated assembly equipment and follow all safety policies fostering a safe work environment
- Work within defined processes and procedures or methodologies (SOPs, work instructions, batch records), with excellent attention to detail following Good Documentation Practices
- Exchanges ideas and information effectively; uses tact and diplomacy when dealing with others
- Maintain a clean and organized manufacturing environment
- Drive towards targeted metrics for quality, efficiency, and on-time completion
- Ability to perform manual assembly processes efficiently and with high quality (i.e. gluing, soldering, hand assembly, kitting/packaging, etc.)
Qualifications
- 2+ years of experience in a regulated manufacturing environment
- Excellent communication, organization, follow-up, and documentation skills.
- Ability to perform multiple manufacturing processes while adhering closely to documented procedures
- Ability to maintain focus performing repetitious and detailed tasks
- Takes pride in quality and efficient execution, adherence to quality standards, and maintaining an organized working environment
- Strong fine motor skills
- Preferred: Experience in medical device assembly and/or in an FDA-regulated environment
- Preferred: Experience with electronics assembly (soldering, wire termination, PCB programming, etc.)
Join our team!
Ontogen offers a comprehensive and competitive benefits package for employees, including 401(k) matching, medical/dental/vision insurance, and PTO. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the U.S. and to complete the required verification document upon hire.
Ontogen Manufacturing is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Pay: $18.00 - $22.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Disability insurance
- Health insurance
- Life insurance
- On-the-job training
- Paid sick time
- Paid time off
- Vision insurance
Experience:
- Mechanical assembly: 2 years (Preferred)
Shift availability:
Work Location: In person
