Manufacturing Engineer, Senior - Northbrook, IL

A Brief Overview The Manufacturing Engineering, Senior will be responsible for: Direct technical support for Instruments and Consumable Manufacturing operations in ISO 13485 and FDA regulated medical device setting.  Representing Operations in design teams for new and on market product design and development, design transfer, and market phases. Facilitating in the definition of project tasks, establishing timelines, and fulfilling responsibilities for product design transfer and related process engineering.  Collaborating on the development and assuming full ownership at Production release of material specifications/drawings, manufacturing processes, repair/refurb processes, fixtures, test methods, analysis tools, and related acceptance criteria for new or on market product. Leading and supporting product, supplier, and process sustaining engineering initiatives to scale manufacturing throughput and improve quality, compliance, safety, yields, efficiency, reliability, and cost.  Leading and supporting the investigation and resolution of findings identified through audits, non-conformances, corrective/preventative actions, or customer complaints. Task-specific and change control training of Manufacturing personnel.  Key technical leader responsible for providing technical leadership for cross-functional projects spanning multiple operations and sites. What you will do Represent Operations in cross-functional design teams to deliver transfer of design changes or new product introduction of instruments and consumables through product development, validation, and market release phases. Assume full ownership of sustaining engineering support for on-market products Lead or assist in sustaining engineering initiatives to support obsolescence management. Lead or assist in product, supplier, and process sustaining engineering initiatives to improve quality, compliance, safety, efficiency, reliability, cost, and scale throughput. Provide technical support for supplier issues Participate and drive development and implementation of process automation strategies and solutions Participate in the design, specification development and selection of new production equipment, such as, test fixtures, manufacturing aids, and automation equipment; includes scale-up of existing processes and development of new processes Lead and assist in engineering change control and document change control activities; participate in change control reviews. Collaborate with R&D on development and assume full design transfer ownership for Production and Market release of material specifications/drawings, manufacturing processes, repair/refurb processes, fixtures, test methods, analysis tools, work instructions and related acceptance criteria for new or on market product. Establish and maintain standard architecture of BOMs and routings; interface with Cost Accounting for new or on-market product COGs roll-up. Collaborate with R&D on OQ process validation planning and execution. Assume full ownership of PQ process validation planning, execution, and reporting. Assume full ownership of equipment, test fixture, test method, analysis tool validation planning, execution, and reporting; collaborate with R&D as required. Ensure effective training of Manufacturing and Quality Control personnel for transfer of new processes. Lead and support the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation. Effectively apply problem solving tools (5 Whys 2 Hows, Is/Is Not, Fishbone, Cause-and-Effect, etc.) toward systematic resolution of issues. Lead and assist in design input, implementation and validation plans, and implementation oversight of infrastructure improvement projects Provide technical leadership for external technology transfers and contract manufacturing transfers. Provide packaging and labeling design support. Lead and participate in cross-functional teams supporting business process improvement and alignment initiatives Responsible for knowledge transfer of new product designs being integrated into operation. Participate in or conduct applicable departmental, interdepartmental and intra-departmental training. Ensure personal compliance and promote operational compliance with the Quality System and other regulations. Ensure compliance to NFPA, OSHA, lock-out, and other applicable safety standards. Other duties as assigned. Education Qualifications Bachelor's Degree Bachelors of Science in the field of Mechanical, Electrical, Industrial, Bio-medical, or Biomechanical Engineering. required Experience Qualifications 8 Years Experience and technical leadership supporting process improvement and sustaining engineering in a ISO 13485 and/or FDA regulated Life Sciences, Medical Device, or Medical Technology industry. required 5 Years Experience working independently or as a team member in a fast-paced relevent environment with rapidly changing priorities required Training and Skills Thorough knowledge of ISO 13485 and FDA Quality System requirements Knowledge of Enterprise Resource Planning, including applied knowledge of engineering functionality Proficiency in the use of Product Lifecycle Management, including applied knowledge of Engineering Change Control Applied knowledge of Process and Test Method Validations as required by FDA Quality System guidelines Knowledge of Design Control requirements as defined by the FDA Quality System guidelines Proven results through application of Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments Mathematics and statistics aptitude. Data analysis and technical writing aptitude. Excellent oral and written communication skills. Geometric Dimensioning & Tolerancing PLC programming Knowledge of BTP, equipment specification; injection molding, material coatings Proficient in Microsoft Word, Excel, and PowerPoint programs. Highly organized with proven time management and prioritization skills Ability to work independently and with minimal supervision Ability to handle the pressure of meeting tight deadlines Travel Requirements 10% Travel may be required Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you. Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.

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