Production Engineer OR Continuous Improvement Eng.

Continuous Improvement Engineer – Plymouth, MN We are seeking a proactive and motivated Continuous Improvement Engineer to support the successful implementation and sustainability of business excellence initiatives at our site. This role plays a critical part in driving cultural transformation, enabling continuous improvement, and ensuring operational standards are upheld across the organization. Key Responsibilities Maintain a strong daily presence on the production floor, acting as the first‑line engineering resource for operators and supervisors. Build deep process knowledge across all stations and understand how work content, takt time, and staffing impact throughput. Support operators in issue resolution, performance visibility, and process adherence. Learn and interpret line balance to understand expected performance at each station and for the entire line. Translate line‑balance expectations into clear, actionable performance goals for operators and supervisors. Adjust monthly goals to reflect changing headcount, learning curves, product mix, and ramp conditions. Measure true line performance and compare it to expected performance from the line balance. Identify stations performing above expectation, validate the root cause of over‑performance, and update goals accordingly. Highlight stations performing below expectation and elevate issues, gather data, or coordinate cross‑functional support. Communicate performance insights effectively to operations teams in a concise and actionable manner. Conduct time studies, observe operator methods, and quantify variation in work steps across operators. Drive cycle‑time consistency, standardize best practices, and reduce variation across the team. Develop and support execution of incremental improvement roadmaps for target stations. Partner with supervisors, technicians, and engineers to implement process improvements, layout adjustments, and waste removal. Facilitate quick feedback loops for issues affecting throughput, quality, or safety. Assist with creation or updates of standard work, operator instructions, and training materials. Support improvement events (Kaizens), rapid experiments, data collection, and pilot runs. Ensure that changes implemented on the floor are followed, measured, and sustained. Required Skills & Competencies Bachelor’s degree in Engineering (Industrial, Chemical, Biomedical, Mechanical, or related discipline). 1–3+ years of experience in medical device manufacturing or manufacturing, production engineering, or continuous improvement. Strong analytical skills with proficiency in basic data analysis tools (Excel, Power BI, or equivalent). Strong communication skills and ability to work closely with front‑line teams. Competency in time studies, takt time analysis, and basic capacity modeling (preferred but trainable). Ability to thrive in a fast‑paced, rapidly evolving production environment. Desire to be involved with day‑to‑day operations – working, shadowing, coaching product builders. Strong self‑starter with strong follow‑up, execution and organizational skills. Process Development Engineer – Pleasanton, CA We are seeking an experienced, high‑caliber Process Development Engineer at our Pleasanton, CA location. This position will design and develop manufacturing processes in order to meet program milestones for the New Product Introduction (NPI) team in the Heart Failure division. What You’ll Do Design and develop manufacturing processes, tooling, and fixtures in order to meet new product program schedules while enhancing productivity and product quality. Drive process improvements and validations through manufacturing implementation; update PFMEAs and master validation plan as required. Author process validation protocols and reports, including but not limited to equipment IQ, process OQ, process PQ, and product PPQ. Understand principles of Cost of Goods Sold (COGS) relative to material, direct labor, and overhead costs in consideration of manufacturing process yields. Utilize various tools (DMAIC, Gage R&R, Cp, Cpk, SPC, etc.) to analyze and improve processes, components, and products. Partner with R&D to ensure adherence to Design for Manufacturability (DFM) principles. Drive change orders impacting manufacturing process documentation, product structure, product/component specification changes & improvements. Understand manufacturing concepts such as Value Stream mapping, 5S, and Visual Workplace to improve quality, labor efficiency, and throughput. Work with cross‑functional teams as required, especially with R&D, Quality, and Regulatory teams. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Education and Experience You’ll Bring Required Bachelor of Science degree in Mechanical, Biomedical, or Electrical Engineering, or equivalent. Minimum 2 years of relevant engineering experience. Demonstrated experience with electronic hardware or software systems. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast‑paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communication skills; ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes, and meets deadlines in a timely manner. Strong organizational and follow‑up skills, as well as attention to detail. Ability to travel up to approximately 10%, including internationally. Preferred Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control. Previous medical device experience. Experience with running change orders in Windchill product lifecycle management software. Use of Design of Experiments (DOE) in process optimization. Cleaning validations. Cleanroom manufacturing best practices. Continuous Improvement Engineer / Kaizen Facilitator / Project Coordinator – Pleasanton, CA Looking for a professional who would like to join the project and make a difference in the medical industry. Main Responsibilities Model processes and unit operations. Identify and resolve constraining bottleneck operations utilizing Value Stream Mapping. Rebalance and configure flow cell designs consistent with current and future state productivity and yield metrics. Develop detailed facilities layouts and serve as leader in facilitating their execution. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Other Requirements Cycle Time Analysis. Process mapping and working on flowchart experience. Visual management and change management. Value stream mapping. 10‑15 years working experience on continuous improvement in line manufacturing environment (not automated environment). Experience within medical devices, preferred manufacturing, chemical or engineering. Consulting or corporate experience. Kaizen facilitator experience. Great communication skills. Working independently with minimal directions. Senior Continuous Improvement Engineer – Pleasanton, CA Senior Continuous Improvement Engineer to work closely with the cross‑functional Value Stream teams. This position will design, develop, standardize and implement Operational Excellence methods intended to continuously improve manufacturing system performance. This individual is an influencer and facilitator, with a track record of managing change. This individual is a systems thinker who solves problems by building relationships and collaborating. Impact this role will have Participate in identification and planning of department goals and budget, development, standardization and implementation of initiatives intended to improve the quality, cost and delivery performance of the organization. Support productivity, quality, process efficiency, space utilization, standardization and lead time improvement efforts in conjunction with the Value Stream teams. Collaborate with the Continuous Improvement Department to support Lean, Six Sigma and DMAIC problem‑solving initiatives. Identify opportunities and drive incorporation of appropriate Lean tools such as 5S, time study, line balancing, standard work, material flow and value stream mapping into daily functions of the Value Stream teams. Collaborate with cross‑functional teams as required. Provide input into departmental budgeting processes as required. May supervise and provide work direction to other engineers and technicians. Understand work environment issues (e.g., OSHA regulations). Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Perform other related duties and responsibilities, on occasion, as assigned. Experience, Education and Knowledge BS in Industrial Engineering or related field or equivalent experience; advanced degree preferred. 5+ years manufacturing engineering experience. Medical device experience preferred. Strong analytical, problem‑solving and project management skills. Demonstrated leadership capability in team settings. Six Sigma or Lean Certification preferred. Experience working in a broader enterprise/cross‑division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast‑paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in a timely manner. Strong organizational and follow‑up skills, as well as attention to detail. Ability to travel approximately 15‑30%, including internationally. #J-18808-Ljbffr Sedaa Corporation