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Penumbra, Inc. · 4 hours ago

Manufacturing Engineering Manager (Medical Device)

San Francisco Bay Area

Full-time

Onsite

Mid, Senior Level

$145K/yr - $214K/yr

5+ years exp

Penumbra, Inc. is a global healthcare company focused on innovative therapies. They are seeking a Manufacturing Engineering Manager to oversee the engineering, design, and development of medical devices, ensuring effective transfer from R&D to production while managing a multidisciplinary project team.

Medical Device

H1B Sponsor Likely

Hiring Manager

Dexter Whack

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

Qualification

Medical device experienceGMP/Quality System RegulationsEngineering managementBachelor’s degree in engineeringProcess developmentCross-functional team leadershipTrainingDevelopmentDocumenting processesMicrosoft OfficeCommunication skillsProblem-solving skills

Required

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

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

Preferred

Master's degree preferred

Benefits

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

Paid sick time in compliance with applicable law(s)

Company

Penumbra, Inc.

Glassdoor3.3

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.

Founded in 2004

Alameda, CA, US

1001-5000 employees

http://www.penumbrainc.com

H1B Sponsorship

Penumbra, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (30)

2024 (42)

2023 (48)

2022 (43)

2021 (36)

2020 (26)