Job Description:

Production Engineer· Full-time, permanent position· Pay Rate: $90K - $100K· Whippany, NJ - Onsite We at Raise are hiring for oneof our key clients in the Life Sciences industry. After establishing themselvesas an industry leader, our client's team is expanding to meet rising demand. They're looking for skilled technical professionals like you to help completemeaningful and impactful projects. This is a role where you can learn and growalongside an experienced team. If you want a job where you can build skillswith an industry leader, this could be it. They're hiring right now; if you're interested, apply today for your chance to join a greatplace to work. Our client takes pride in their people. When you join their team, you'll find a workplace that facilitates challenge, achievement, and growth.Position Title: Production EngineerReports To (Title): Engineering Manager BASIC FUNCTIONThis position resides in the Engineering Department. Responsibilities include supporting production processing, fixture and tooling design, maintenance, and production process validations, as well as supporting continuous improvement activities for manufactured medical devices. MAJOR RESPONSIBILITIES 1. Serves as the primary Production Engineer with responsibility for ensuring all equipment and manufacturing processes are qualified and adequate for process procedures and manufacture of consistent product. 2. Interacts with the production manager to address any process improvements or fixture and tooling adaptations to improve product and product production flow. 3. Maintains the process specification and the associated maintenance records for all production equipment and fixtures.4. Establishes all aspects of production validation, including but not limited to, authoring reviewingexecuting, and commissioning Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocolfinal reports, and periodic validationqualification reviews. Interacts with the Quality Engineer for risk assessment and regulatory requirements.5. Works with facilities, operations, purchasing, etc., in the development, execution and change control of production processes and protocols.6. Supports continuous improvement and lean initiatives to identify and drive out waste from current manufacturing processes while maintaining the highest level of quality.7. Works independently andor within a team on specialnon-recurring ongoing projects.8. Performs other duties as assigned. JOB REQUIREMENTS Education:- BS in Mechanical Engineering or equivalent, Master's degree a plus. Experience & Expertise:- Minimum of three (3) years' experience working in a production environment or similar position. Prior exposure to Medical Device industryworking in compliance with ISO 13485 and FDA 21 CFR Part 820 Quality System Regulations is a plus.- Good understanding of measurement system analysis including Gage R & R.- Experience with manufacturing procedures and fixture implementation. - Experience performing accurate mechanical, physical and visual inspection when required as per specification utilizing various measuring equipment (i.e., calipers, micrometers, tensile tester, etc.).- Must have the ability to generate tooling and fixture drawings in AutoCadAutoCad Inventor. - Ability to use statistical techniques.- Familiar with Good Manufacturing Practices (GMP).- Excellent communication and interpersonal skills - must have the ability to clearly communicate with plant personnel at all levels.- Capable of composing technical detailed written reports and other communications as required.- Excellent organizational skills with the ability to handle multiple priorities and deadlines.- Proven record of success working in a fast-paced, high pressure, deadline-driven work environment.- Proficiency with various software programs; including but not limited to, MS Office (Word, Excel, PowerPoint), AutoCadAutoCad Inventor. Physical Demands:- Required to stand for long periods of time.- May involve some repetitive motions.- Must be able to lift up to 25 pounds.- May also engage in frequent bending, stooping, squatting, pushing, and pulling.