Manufacturing Engineer

MANUFACTURING ENGINEER Are you looking for more than a job?

Would you like to work somewhere that offers you the chance to grow personally and professionally?

Someplace where your efforts have a significant impact on the lives of others?

THE COMPANY: We are WillowWood Global LLC, a well-established industry leader in providing prosthetic and orthotic products to clinicians and amputees around the world.

As the Environmental Health and Safety Manager your efforts will be vital in helping us achieve our vision of "leveling the playing field" between physically unchallenged people and all people who find themselves challenged due to limb loss or limb dysfunction.

THE POSITION: This position supports the development and implementation of process improvements for optimal and efficient operation of existing processes for medical device products.

Provides engineering support for new product manufacturing processes and process introductions, ensuring that all activities are completed and documented in accordance with the company's procedures.

Supports current production, providing technical solutions to meet safety, quality and cost efficiency goals.

Supports and leads continuous improvement initiatives, documentation, data analyzation, new tooling and equipment requirements, new product launches and continuous improvement projects.

Primary Responsibilities Participates on the process engineering team in support of daily and long-term production goals.

Applies lean manufacturing techniques to design, specify and validate world-class manufacturing processes to achieve safety, quality, and production goals and uses techniques and tools to reduce waste and improve productivity.

Assignments will typically be of moderate to high size & complexity, or he/she may be assigned responsibility for part of a more complex project.

Works closely with operations, quality, and product development to prioritize and plan project work.

Participates in the completion of root cause analysis to understand long term improvement needs in order to address equipment efficiency and quality defect reduction.

Supports the development and implementation of new product/process requiring new technologies from project proposal through post-launch quality assessment.

Responsible for cost analysis (ROI calculations). Ensures change management procedures are followed and changes are properly documented per the quality system.

Works with operations, purchasing and product development to identify opportunities with raw material processing as well as introduction of new materials into products Support projects that deliver achievement of the plant cost savings opportunities.

Completes manufacturing documentation for products, to include ERP system set up, component drawings and specifications, inspection plans, bill of material and routing, assembly and packaging drawings, standard operating procedures (SOPs), work instructions, quality plans, equipment validation documents (IQ/OQ/PQ) and other required documents.

Ensures all documents are generated and in compliance with company quality system and customer requirements.

Adapts and leads change constructively supporting ongoing improvement throughout the business.

Participation in vendor assessments Product reports and customer concerns Internal quality audit participation May be responsible for the oversight and development of Manufacturing Engineering Technicians both technical and professional Education and Experience Bachelor's degree in Manufacturing, Industrial, Biomedical, or Mechanical Engineering Disciplines preferred 2+ years of applied professional experience in process engineering or related manufacturing field Medical Device manufacturing experience, with understanding of ISO13485:2016 preferred Lean Six Sigma green belt preferred Knowledge, Skills and Abilities Exceptional indirect leadership capabilities Strong written and verbal communication skills Effective project management skills Serve as a change agent to drive process improvement and cultural change Creates alignment, must be adaptable and flexible Works well under pressure, effectively handles conflict, strict deadlines and multiple tasks/priorities Excellent organization, record keeping and documentation practices Required Be able to deal with a variety of emotions, frustrations in making business decisions.

Emotional stability and personal maturity are important attributes of this position.

Be able to analyze many variables and choose the most effective course of action for the organization at any given point in time.

Handle novel and diverse work problems on a daily basis.

Be able to communicate and provide verbal feedback in a professional manner Be able to resolve problems, handle conflict and make effective decisions under pressure.

Requires excellent interpersonal skills.

Support compliance for GMP, ISO 13485:2016, MDD/MDR, and safety.

Leadership/Personal Experience Customer centric Accountable Collaborative Active listener Self-Motivated Strong desire to learn and improve Detail oriented High quality standards Technical Experience Analytical Awareness of Root Cause Analysis (RCA) tool leadership capability Awareness of Non-Conformance (NC), CAPA and Complaint investigation processes in medical device manufacturing Project management Understanding modern medical device manufacturing operation Lean Six Sigma principles Demonstrate understanding and application of IQ/OQ/PQ Awareness of GMP, ISO13485:2016 Understanding of Change Control Awareness or demonstrated use of tools such as Define Measure Analyze Improve Control (DMAIC), Failure Modes & Effect Analysis (FMEA), Design of Experiments (DOE), Gage Repeatability & Reproducibility (Gage R&R), and Statistical Process Control (SPC) Demonstrated experience with SolidWorks.

Should be capable of developing 2D drawings, manipulating 3D assemblies and modeling complex figures and gauges.

We are an Equal Opportunity Employer.

We recruit, hire, promote, transfer and provide opportunities for advancement on the basis of individual qualifications and job performance.

In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, we will not discriminate against any employee or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, disability, or status as a covered veteran.

Full Time