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Manufacturing Engineer

1 month ago


Irvine, United States Baltgroup Full time

About Balt Our purpose is to improve the lives of 150,000 patients in 2026. Our story Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting. We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space. We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives. Why Join Balt? Join a passionate team, dedicated to making a difference. Working at Balt means giving meaning to your work Pride is a strong part of our identity. We are a close-knit team, with strong mission, vision and values that guide our day-to-day. Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success. No matter the country, we take care of you. Would you like to be part of our story? Don't hesitate, come and join us About this opportunity – Manufacturing Engineer Description You will have the responsibility to support and continuously improve current manufacturing processes, through technical and process innovation for the manufacturing of neurovascular medical devices that save patient lives. Job Responsibilities: Create and execute test protocols to qualify and validate manufacturing processes; analyze results, make recommendations, and complete reports. Draft, approve, and execute equipment qualifications Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Smartworks, Risk Analysis, etc.). Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design and ensure equipment, tools and fixtures are up to standards. Guide manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work. Identify, plan, and execute CIP projects via 2 nd sourcing, process/fixture/equipment improvements etc. Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) as applicable. Perform other duties and responsibilities as assigned. Qualification Requirements: Bachelor's Degree in Engineering or Scientific field. Minimum of 2 years’ experience in medical device manufacturing engineering and production support or minimum of 4 years in another regulated industry. Skills: Medical device manufacturing experience in coils, catheters, winding, braiding is preferred. Advanced degree is preferred. Familiarity with DFM and LEAN is preferred. Proven expertise in usage of MS Office Suite including MS Project; MES and/or CAD experience preferred. Strong verbal/written communication and interpersonal skills. Strong project management skills. Basic understanding of statistical techniques. Previous experience in a manufacturing support role preferred. Strong problem-solving, organizational, analytical and critical thinking skills. Process Validation experience. Capable of analyzing and solving complex problems through innovative thought and experience. Ability to manage competing priorities in a fast-paced environment. Ability to work well independently as well as part of a team. Good leadership skills and ability to influence change. Ability to interact professionally with all organizational levels. Excellent written and oral communication skills Team player with a commitment to developing strong collaborative relationships with colleagues, business partners and cross-functional teams. Extended periods of sitting. Extended computer usage. Light lifting. Work Environment Working conditions are normal for an office environment. The above information on this description has been designed to indicate the general nature of work performed by employees within this position. It is not a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Balt Group is an Equal Employment Opportunity employer. More information please go to www.baltgroup.com Warning : There are job offer scams impersonating companies like Balt Group. Legitimate correspondence will only come from "@baltgroup.com" emails. #LI-FW1 #J-18808-Ljbffr