Medical Device Manufacturing Engineer

Description:

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.

• 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

• 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 and climbing all 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.

Benefits:

401(k)

401(k) matching

Dental insurance

Employee assistance program

Employee discount

Flexible spending account

Health insurance

Health savings account

Life insurance

Paid time off

Parental leave

Referral program

Retirement plan

Vision insurance

Skills:

Manufacturing engineering, IQ/OQ/PQ, Validation, Cleanroom, Lean, Six SIgma, ISO13485, Design, SOlidworks, fixture design, Jig, Documentation

Top Skills Details:

Manufacturing engineering,IQ/OQ/PQ,Validation,Cleanroom,Lean,Six SIgma,ISO13485,Design,SOlidworks,fixture design,Jig,Documentation

Additional Skills & Qualifications:

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

• Expereince 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

Experience Level:

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.