Production Engineer

· Full-time, permanent position

· Pay Rate: $90K – $100K

· Whippany, NJ - Onsite

We at Raise are hiring for one

of our key clients in the Life Sciences industry. After establishing themselves

as an industry leader, our client’s team is expanding to meet rising demand.

They’re looking for skilled technical professionals like you to help complete

meaningful and impactful projects. This is a role where you can learn and grow

alongside an experienced team. If you want a job where you can build skills

with an industry leader, this could be it.

They’re hiring right now; if you’re interested, apply today for your chance to join a great

place 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 Engineer

Reports To (Title): Engineering Manager

BASIC FUNCTION

This 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/ reviewing/executing, and commissioning Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocol/final reports, and periodic validation/qualification 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 and/or within a team on special/non-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 industry/working 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 AutoCad/AutoCad 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), AutoCad/AutoCad 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.