Job#: 2049604
Job Description:
We are seeking a Sr Manufacturing Engineer to work in the Medical Device Industry. Please apply to learn more.
The Senior Manufacturing Engineer is responsible for developing manufacturing processes, qualifying changes to products, running validations, and associated tools. Reviews new design changes for manufacturability. Designs process improvements to reduce product cost, process cycle time and improved product quality.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Create documentation to support new and improved manufacturing processes
- Write and perform process validations
- Make recommendations for equipment purchases based upon manufacturing needs
- Perform IQ/OQ/PQ as required on equipment
- Disposition NCRs and CAPAs as assigned
- Perform experiments including but not limited to DOEs to characterize and improve processes
- Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis
- Coordinate with suppliers and external resources needed in developing and implementing new processes
- Work closely with R&D and Manufacturing to capture and interpret design intent in order to refine and improve processes
- Facilitate excellent communications between all team members
- Responsible for communicating business related issues or opportunities to next management level
- For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures
QUALIFICATIONS
- Bachelor degree required - majors that would fit the role are below with the priority also in order Mechanical Engineer, Electrical Engineer, or Industrial Engineer
- 3-5 years related work experience, preferably in a medical device manufacturing environment preferred
- Excellent hands on communication and interpersonal skills
- Experienced in MS Word, Excel, and Project Experience in Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process.
- Failure Mode and Effects Analysis (FMEA)
- Strong Lean Manufacturing background preferred.
- Must be able to multitask and operate in a fast-paced environment with minimal training and supervision.
- Strong written, verbal, and interpersonal skills.
- Ability to effectively interact with all levels of employees and management, both in the Manufacturing group and crossfunctionally
- Understanding of regulations related to FDA, GMP/MDD, and ISO preferred
Skills: MEDICAL DEVICE, FDA, EXCEL, ISO, IQ/OQ/PQ
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.