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Job Description
Sr Director, Manufacturing Engineering (NPI) MicroVention, Inc. - 2.9 Aliso Viejo, CA Job Details $204,000 - $268,500 a year 14 hours ago Qualifications Stakeholder engagement Manufacturing management New product introduction engineering projects Microsoft Outlook Team leadership Design of manufacturing processes Design of experiments Six Sigma methodology implementation Project management in manufacturing Policy & process development Medical device manufacturing facility experience Technology transfer (scale-up process) Microsoft Teams Regulatory/legal compliance standards in production Project budget management Quality standards in production Project management software Design for manufacturability (DFM) Biomedical regulatory compliance Managing projects Biomedical manufacturing processes Quality improvement programs in engineering Research & development Technical Proficiency Stakeholder relationship building Senior leadership Stakeholder management Full Job Description Lead the strategy and execution of manufacturing engineering activities for new product development within the medical device industry. Responsible for driving design for manufacturing (DFM) principles, ensuring seamless operations integration, and achieving successful industrialization and scale of innovative products from concept through commercial launch.
Job duties:
Lead NPI manufacturing engineering strategy by defining and implementing best practices within new product development, ensuring alignment with business objectives and regulatory requirements. Design for manufacturing excellence by partnering with R D to optimize product designs for manufacturability, cost efficiency, and scalability.
Process development and capability:
Oversee process development, design of experiments (DOE), and validation activities to ensure robust, repeatable, and compliant manufacturing processes.
Operations integration:
Collaborate cross-functionally with Operations, Quality, and Supply Chain to integrate new products into production environments seamlessly.
Industrialization and scale:
Drive readiness for high-volume production, ensuring smooth transition from pilot builds to full-scale manufacturing. Ensure continuous improvement by applying Six Sigma engineering principles and maintain Black Belt certification standards to improve process capability and reduce variability.
Leadership and team development:
Build and mentor a high-performing team of manufacturing engineers and technical experts. Perform design and manufacturing engineering analysis using geometrical dimensioning and tolerancing and process capability studies. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. Perform additional duties as assigned. Job Details Job
ID 13852BR
Aliso Viejo, California, USA Salary Range:
$204,000 - 268,500 (Compensation coujld be higher/lower based on experience, education and skill sets) Qualifications Bachelor's degree in engineering or science. Minimum of fifteen (15) years of relevant professional experience in production, manufacturing engineering, R D engineering, and process development engineering roles. Minimum seven (7) years of management or leadership responsibility/experience. Proven track record of design for manufacturing and successful commercial scale-up of new product introductions. Strong knowledge of Six Sigma engineering (Black Belt trained and certified). Expertise in the design of experiments, process capability, and process development methodologies. Experience in medical device manufacturing with deep understanding of regulatory and quality requirements. Proven track record of successfully managing complex projects and delivering results on time and within budget. Exceptional leadership, written and verbal communication, and stakeholder management skills. Proficiency in project management software and tools and MS Office Suite, including Word, Excel, Outlook, and Teams. Desired Qualifications Advanced degree in a relevant field of study. Project Management Professional (PMP) certification. EEO We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law. Fair Chance Ordinance If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.
