General Summary
Provide management in the engineering, design and development of new products or changes to existing products, processes, and equipment. Direct the transfer and scale-up of products from R&D to Production. Exercise judgment within generally defined practices and policies in determining project plans (milestones, resources) and selecting methods and techniques for meeting project goals.
Specific Duties and Responsibilities
•Manage the manufacturing engineering functions of development projects within a multidisciplinary project team. *
•Manage the development, implementation and maintenance of processes and equipment for manufacturing of products to achieve cost effectiveness and product quality. *
•Navigate Quality System fluently and lead others through quality system justifications. *
•Select, manage, train and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. Manage direct reports to execute tasks and achieve goals *
•Lead cross-functional teams fluently through agreed-upon strategic guidance *
•Provide engineering support to operations as needed. Leads other engineers. *
•Execute tasks independently and does not require assistance nor guidance. Recommend vetted solutions proficiently and generate unique projects independently. *
•Work with product development teams to ensure design for manufacturability. *
•Create drawings for Production and Research and Development. *
•Document manufacturing and production development processes through lab notebooks, engineering protocols, and engineering reports. *
•Identify and utilize vendors in the development of processes for Penumbra, Inc. products. *
•Perform research and integrate new technologies into existing and future products and processes. *
•Train engineers, technicians and assemblers in new processes and methods. *
•Evaluate and troubleshoot problems to assess root cause and corrective action. *
•Interpret and communicate test results. *
•Document findings and recommendations. *
•Create and modify product design specifications. *
•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
•Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
•Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
•Perform other work-related duties as assigned.
*Indicates an essential function of the role
Position Qualifications:
•Minimum education and experience:
•Bachelor’s degree in an engineering or related technical field with 5+ years of relevant experience, or an equivalent combination of education and experience
Additional qualifications:
•Experienced working with medical device contract manufacturers and suppliers.
•Working knowledge of PCBAs, Injection molding, and other commonly outsourced processes.
•Master’s degree preferred
•Medical device experience required
•Detailed knowledge of GMP/Quality System Regulations and clean room environment practices
•Outstanding knowledge of engineering and scientific principles
•Demonstrated ability to motivate and lead teams
•Excellent written, verbal and interpersonal skills required, including the demonstrated ability to motivate and lead teams, and provide coaching and supervision of direct reports
•Proficiency in Word, Excel, PowerPoint, Access and other computer applications required
Working Conditions
•General office, laboratory, and cleanroom environments
•Willingness and ability to work on site.
•May have business travel from 0% - 15%
•Potential exposure to blood-borne pathogens
•Requires some lifting and moving of up to 25 pounds
•Must be able to move between buildings and floors.
•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
•Must be able to read, prepare emails, and produce documents and spreadsheets.
•Must be able to move within the office and access file cabinets or supplies, as needed.
•Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Location and Pay
•Alameda, CA
•$145,000 and $214,000
•Individual compensation will vary over time based on factors such as performance, skill level, competencies, work location, and shift.
What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
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Are you ready to take the next step in your engineering career? Penumbra, Inc. in Alameda, CA is on the lookout for a Manufacturing Engineering Manager – Electromechanical! In this role, you will be at the forefront of managing engineering and design projects that create innovative medical products. Your expertise will guide cross-functional teams as they transition new ideas from R&D to production, ensuring that the end products are both cost-effective and high-quality. You will leverage your experience with medical device contract manufacturers and your knowledge of PCBAs and injection molding techniques to develop manufacturing processes that meet stringent quality standards. Continuous improvement will be a focal point as you implement and maintain state-of-the-art processes while navigating quality systems fluently. Plus, leading and building a strong team of engineers isn't just part of your job -- it’s what drives you. As you create and modify product specifications and troubleshoot problems, you’ll feel the satisfaction that comes from making a real difference in healthcare. With a generous compensation package and a collaborative environment that promotes learning and growth, Penumbra is the perfect place for you to thrive and revolutionize treatment for some of the world’s most challenging medical conditions. So if you have a passion for engineering and want to work on products that matter, join us at Penumbra and be part of that change!
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Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical ...
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