Manufacturing Engineer

Job Summary: Responsible for developing Lean solutions for production and manufacturing engineering. Support programs by optimizing processes and developing tooling and equipment.

RESPONSIBILITIES:

· Develop manufacturing processes, work instructions, routings and develop necessary production tooling.

· Be a key contributor in the creation of PFMEAs.

· Support production builds.

· Perform root cause analysis to resolve manufacturing and production system downtimes and provide technical information to support corrective actions and improvements.

· Develop and qualify specialized assembly tooling and equipment (IQ, OQ, PQ)

· Write and execute test protocols.

· Analyze process data to reduce material scrap and to optimize processes.

· Document all manufacturing processes in accordance with our ISO standards.

· Interface with outside vendors for manufacturing, measurement, and test equipment selection.

· Read and interpret technical drawings, product specifications, technical and regulatory requirements, and computer-generated reports.

· Design and implement inspection strategies, including control plans, measurement techniques, and gauging.

· Leading and implementing Lean initiatives that include designing and implementing continuous improvements, developing best practices, measuring process improvements, and establishing visual management and ensure implementation of best practices for production.

· Apply statistical methods and perform mathematical calculations to determine manufacturing processes, staff requirements, production standards, value stream mapping, Kaizen, Kanban, setup time reduction, single piece / small batch process flow, 5S process, machine capability studies, Cpk/Ppk, X-Bar&R charts, establish control limits, etc.

PREREQUISITES:

· Bachelor’s Degree in Engineering or equivalent (Mechanical preferred)

· Minimum five (5) years of manufacturing engineering experience in a controlled environment such as ISO 13485

· Experience with ERP systems

· Proficient in Solid Works CAD Software

· Working knowledge of inspection methodologies

· Experience with the generation, release, and change control of various document types.

REQUIRED SKILLS:

· Strong verbal and written communication skills

· Strong troubleshooting and evaluation intuitiveness

• Excellent problem solving and time management skills
• Works precisely and pays close attention to details
• Strong mechanical aptitude and knowledge
• Self-motivated and highly organized

· Good interpersonal skills, tactful, mature and flexible

· Strong supporter and an advocate of company values.

· Knowledge of electronic equipment and computer hardware and software, Excel, MS office

PREFERRED SKILLS:

• Strong knowledge of LEAN, Six-Sigma, SPC, Shainin, and other process capability and problem-solving tools.

· Background in the Medical Device industry

· Experience with precision machining and machine tools

· Knowledge of automated assembly equipment and techniques.

· Experience with plastic injection molding and injection molding systems

· Proficient with Design for Manufacturability (DFM) practices and LEAN Manufacturing principles

· Familiar with ultrasonic welding of plastic materials

· Knowledge of material cleaning and passivation processes

· Clean room assembly practice (cGMP) experience

· Laser marking of plastic and stainless steel

Work Environment: While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts and vibration. The employee is frequently exposed to a variety of varying weather conditions, trash, waste, chemicals, and other materials. The noise level in the work environment and facility grounds can be loud. In some situations, employee may need to work in front of a workstation or desk for several hours at a time, analyzing data or creating reports.

Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk, see and hear. This position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, during the day. The employee must frequently lift up to 40 pounds or move items over 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Job Type: Full-time

Pay: $106,164.00 - $115,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person