Job Overview
Ontogen Manufacturing is seeking a dynamic and experienced Senior Manufacturing Engineer to join our team. The ideal candidate will possess knowledge of medical device manufacturing and have experience transferring medical devices from design to production. The position requires a creative engineer to work on developing manufacturing processes for a wide range of assembled medical devices as a contract manufacturer.
Responsibilities
- Interface with Clients and lead new product introductions from development into manufacturing.
- Develop and control efficient manufacturing processes for a range of medical devices
- Assist in or lead the development of a robust product realization program to serve our clients’ contract manufacturing needs
- Own and maintain design and process documentation including Item Specification, Process Work Instructions, BOM, Drawings, etc. once transferred from development
- Perform change management, including creation and routing of change orders, identifying appropriate process impacts, risks, and justification for change
- Identifying and procuring manufacturing equipment ranging from custom large-scale PLC/PC -based automation equipment to small fixturing
- Own, plan and execute design transfer activities, including validation of equipment and processes, requirements creation, Master Validation Plans, IQ/OQ/PQ Protocols and Reports, Test Method Validation, Process Flow Diagrams, pFMEA, etc
- Assist with or lead calibration and maintenance activities to ensure compliance with Ontogen or our clients’ quality system, including troubleshooting of automated equipment
- Assist in training technicians according to documented manufacturing processes
- Lead cost reduction, capacity scaling, and quality improvement activities (equipment and manpower) to meet business needs
- Participate in or lead CAPA investigations, NCM resolution, failure and root-cause analysis, and other investigation activities
- Ensure compliance with Quality System Requirements within an FDA regulated manufacturing environment
- Leverage a strong understanding of manufacturing metrics to appropriately select process indicators that quickly and effectively communicate product and process health
- Collaborate closely with cross-functional teams including internal and client team members throughout the development and design transfer process
Qualifications
- BS/MS degree in Mechanical Engineering or equivalent.
- 5+ years of experience in FDA regulated product development or manufacturing desired.
- Excellent communication, organization, follow-up, and documentation skills.
- CAD experience (Solidworks preferred).
- Strong understanding of design control processes, manufacturing processes, and supplier management.
- Excellent analytical and problem-solving skills, with keen attention to detail.
- Effective communication and interpersonal skills, with the ability to collaborate across teams and with clients and suppliers.
- Demonstrated ability to work independently and make sound decisions in a fast-paced environment.
- Experience working in a startup, small company or contract manufacturer strongly preferred.
- Experience with complex electro-mechanical assembly preferred.
Join Our Team!
Ontogen offers a comprehensive and competitive benefits package for employees, including 401(k) matching, medical/dental/vision insurance, and unlimited 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: $105,000.00 - $125,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Application Question(s):
- Will you now or in the future require visa sponsorship
Education:
Experience:
- Regulated manufacturing environment: 5 years (Preferred)
- Product Development or Manufacturing: 5 years (Preferred)
Ability to Commute:
- Lisle, IL 60532 (Preferred)
Work Location: In person
