Manufacturing Engineer

Manufacturing Engineer West500 Partners Kirkland, WA Job Details Full-time | Contract $85 - $90 an hour 1 hour ago Benefits Dental insurance 401(k) Flexible schedule Qualifications Teamwork Interpersonal skills Six Sigma Green Belt ISO standards Bachelor of Science Statistical Process Control Six Sigma methodology implementation Medical device manufacturing facility experience Regulatory/legal compliance standards in production Quality standards in production Design for manufacturability (DFM) Biomedical regulatory compliance Biomedical manufacturing processes Quality improvement programs in engineering Full Job Description A fast growing Kirkland client seeks a senior manufacturing engineer for a long term contract (and potentially to perm). The Senior Manufacturing Engineer develops and documents processes for the manufacturing of medical devices from concept through production. Ensures design for manufacturability through concurrent engineering practices. Is technical lead in the Design Transfer of designs and processes to suppliers.

ESSENTIAL DUTIES

Work with R D and Suppliers to prevent safety/ergonomic concerns with designs Work with R D and Suppliers to design Manufacturing Processes that have strong process capability and are highly controllable Work with R D and Suppliers to ensure Design for Excellence is incorporated into new designs and demonstrated during product development. Ensure assigned processes and process changes are compliant and documented in accordance with our client's procedures and applicable regulations Evaluate designs in order to ensure manufacturability, concurrently with development Ensure designs are transferred correctly to suppliers, develops process verification/validation plans/protocols with suppliers, and reviews reports for completeness and accuracy Investigate Supplier yield issues, and works with R D and Supplier to resolve Investigate field failures that are related to manufacturing processes to determine root cause, corrective action, and preventive action plans. Support the integration of manufacturing operations and outputs into DME tracking business systems. Uses 6-sigma techniques to evaluate new designs/processes and improve existing process

COMPETENCIES

Passion:

Contagious excitement about the company - sense of urgency. Commitment to continuous improvement.

Integrity:

Commitment, accountability, and dedication to the highest ethical standards.

Collaboration/Teamwork:

Inclusion of Team Member regardless of geography, position, and product or service.

Action/Results:

High energy, decisive planning, timely execution.

Innovation:

Generation of new ideas from original thinking.

Customer Focus:

Exceed customer expectations, quality of products, services, and experience always present of mind.

Emotional Intelligence:

Recognizes, understands, manages one's own emotions and is able to influence others. A critical skill for pressure situations. Strong verbal and written communication skills Strong understanding of statistical techniques such as SPC, DOE, and 6-Sigma techniques to develop robust processes, control them, and improve them Provides Project Management support for internal teams and Suppliers to accomplish Objectives Strong process knowledge in molding, bonding, wire harness assembly, and final assembly/test operations.

QUALIFICATIONS

Education/Experience Required:

Bachelor's of Science in Manufacturing Engineering, Industrial Engineering, or Mechanical Engineering Minimum of 5 years' experience Medical device manufacturing experience Familiarity with FDA QSR and

ISO 13485

medical device regulations Excellent interpersonal and communication skills Experience developing highly capable processes using DFX and Six-Sigma techniques

Preferred:

Experience in product development and design transfer to contract manufacturers preferred Knowledge of ISO, FDA, UL and CE requirements as they relate to manufacturing Demonstrated cross-functional team effectiveness Experience as a Project Manager working with contract manufacturers Design for six-sigma, six-sigma green belt certification

WORK ENVIRONMENT

Indoor open office environment Minimal noise volume typical to an office environment Extended hours when needed Drug-free

PHYSICAL DEMANDS

Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage Frequent computer use Frequent stationary position, often standing or sitting for prolonged periods of time Frequent phone and other business machine use Occasional lifting required up to 25 pounds TRAVEL Occasional travel may be required, less than 20% Apply today!

Pay:

$85.00 - $90.00 per hour

Benefits:

401(k) Dental insurance Flexible schedule

Work Location:

Hybrid remote in Kirkland, WA 98033