Manufacturing Engineering Manager - Metals

1 Month ago • 5 Years + • $145,000 PA - $214,000 PA

Job Summary

Job Description

The Manufacturing Engineering Manager will manage the engineering, design, and development of new products or changes to existing products, processes, and equipment. They will oversee the transfer and scale-up of products from R&D to Production, manage manufacturing engineering functions within a multidisciplinary team, and ensure cost-effectiveness and product quality. This includes leading cross-functional teams, providing engineering support to operations, creating drawings, and documenting processes. The role requires a deep understanding of GMP/Quality System Regulations and the ability to train and troubleshoot. This role reports directly to the appropriate management level. The role requires the candidate to be proficient in Word, Excel, PowerPoint, and Access. It also requires adherence to the Company's Quality Management System (QMS).
Must have:
  • Bachelor’s degree in engineering or related field with 5+ years of experience
  • Medical device experience required
  • Detailed knowledge of GMP/Quality System Regulations
  • Ability to motivate and lead teams
  • Excellent written, verbal and interpersonal skills
Good to have:
  • Master’s degree preferred

Job Details

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 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.
What You'll Bring •Bachelor’s degree in an engineering or related technical field with 5+ years of relevant experience, or an equivalent combination of education and experience •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 •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.

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About The Company

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