Manufacturing Engineering Manager (Medical Device) (Fremont)

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.

What You'll Work On

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 Companys 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.

What You'll Bring

Bachelors degree in an engineering or related technical field with 5+ years of relevant engineering experience, or an equivalent combination of education and experience

Masters 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.

Working Conditions

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.

Location and Pay

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.

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 Penumbras commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.