Manufacturing Engineering Manager - Metals​/Catheters

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.

• 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.

• Bachelor's degree in an engineering or related technical field with 5+ years of relevant engineering experience, or an equivalent combination of education and experience.
• Master's degree preferred.
• 1+ years of engineering management and direct employee management experience.
• 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.
• 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.

General office environment. Business travel from 0% - 10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

• Alameda, CA
• Starting Base Salary is $145,000/year - $214,000/year.
• Individual compensation will vary over time based on factors such as performance, skill level, competencies, work location and shift.

• 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…