Manufacturing Process Engineer - Radiant Systems : Job Details

Duration: 1 year( Possibility to extend to FTE)

Education:

• Bachelor of Science degree in Mechanical, Chemical, or Industrial Engineering.

• Other engineering-related degrees will be considered with relevant experience.

Skills:

•7+ years of hands-on experience in a fast-paced manufacturing environment, preferably in medical equipment or devices.

• Demonstrated experience designing, building, and maintaining small tools and fixtures using Creo or related software packages.

Accountability / Responsibility:

• Identifying and optimizing product/process variables required for maximizing product/process performance at prototype, lab/pilot, and full production scale

• Leading evaluation of final product specifications by prototyping products/processes and performing experiments; from lab to production scale

• Developing novel process/tooling concepts for new process development, and evaluate concepts based upon manufacturing key performance indicators (KPIs)

• Proving product/process performance at prototype, lab/pilot scale, and full production scale

• Leading evaluation of scale up options, selection, & implementation by leading sub projects, providing project updates, and offering input for the next phases

• Evaluate, identify and recommend/implement improvements (productivity, efficiency, reliability) to existing processes (melt processing, chemical, machining or mechanical) or products.

• Support research efforts related to identifying and/or evaluating new technologies, biomaterials and/or medical implants.

• Support Operations to address plant layout, resources, and start up milestones

• Developing all necessary documentation to support new/or improved process scale up to manufacturing verification

• Design, assemble and test semi-automated and automated tooling required to improve current processes, or needed for new projects/product lines

• Create and/or process ECN's, process routers, drawings, and other written documentation in accordance with GMP requirements to support product development, process development, validations and manufacturing.

• Leading evaluation of potential new product/process proposals and provide recommendations as to the scope and necessary timing required for specific production targets

• Developing project plans, estimating project costs, operating costs, project schedules milestones, and resource requirements.

• Support customer quotations for new/changes to products/processes

• Leading improvement of infrastructure and capabilities

• Analyzing results of experiments against objectives/targets

• Working with supervisor and other associates to ensure execution of experiments in a timely manner

• Leading Machine design verifications reviews.

• Support Design Verifications, Design & Development reviews, and Verifications & Validations for new product development.

• Providing in-house development and/or technical support to Operations

• Conducting investigations and implementation of improvements into manufacturing product/processing issues

• Support Operations in the daily manufacturing of commercial products.

• Conducting investigation into customer complaints and resolution as it relates to manufacturing process, equipment or product requirements

• Providing in-house development and/or technical leadership to Operations

• Leading continuous improvement on projects/processes to achieve improvements in productivity, yield and/or operating costs

• Following Design Control and Risk Management procedures

• Participate in auditing medical device design history files

• Leading investigation and perform root cause analysis into customer complaints

• Support preparation of applicable technical sections for grants, patent, & regulatory filings

• Leading Management of Change (MOC) review process

• Directing or participating on project teams within the PMP/Project Management process

• Execute the job within the applicable GMP, OSHA, EPA, ISO, FDA, CE, & other requirements.

• Directing or participating in a variety of projects with cross-functional project teams. Collaborating with Strategic Business Innovation, Strategic Business Management, Research & Development, Quality, Regulatory, Safety, Finance, & Manufacturing groups.

• Participating on Engineering Change Notice (ECN) Board