Senior Manufacturing Engineer
Job Summary
Job Description
The Sr Manufacturing Engineer provides leadership in the engineering, design, and development of new or modified products, processes, and equipment for neurovascular devices. This role involves interfacing with multidisciplinary teams, providing engineering support for existing devices, and developing, configuring, and troubleshooting processing and test equipment. Key responsibilities include researching and evaluating automated processing equipment, specifying fixtures/tooling, and managing projects within a team environment. The engineer will also train staff, evaluate and troubleshoot problems to assess root cause and corrective action, and document findings and recommendations. Adherence to the Company's Quality Management System and relevant regulations is crucial.
Must have:
- Bachelor's degree in engineering or related technical field
- 4+ years of engineering experience
- Develop new processes for medical devices
- Manage projects independently
- Document manufacturing processes
- Evaluate and troubleshoot problems
- Adhere to Quality Management System
Good to have:
- Master's degree
- Knowledge of GMP/Quality System Regulations
- Experience in the medical device industry
- Clean room environment practices
- Knowledge of engineering and scientific principles
- High proficiency with computers and software
Perks:
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- AD&D insurance
- Short-term disability insurance
- Long-term disability insurance
- 401(k) with employer match
- Employee stock purchase plan
- Paid parental leave
- Eleven paid company holidays
- Minimum of fifteen days of accrued vacation
- Paid sick time
2 skills required
Job Details
General Summary
The Sr Manufacturing Engineer provides leadership in the engineering, design and
development of new products or changes to existing products, processes, and equipment.
Interfaces with and furnishes scientific knowledge to multi-disciplinary teams overseeing
development of neurovascular devices. Provide engineering support on existing devices for
manufacturing. Develop, configure, and troubleshoot processing and test equipment.
Research, identify and evaluate automated processing equipment. Specify fixtures/tooling for
automated equipment support.
Specific Duties and Responsibilities
• Fluently navigate quality management systems within scope and have general
knowledge of quality systems beyond scope. *
• Develop new processes for medical devices and components *
• Execute tasks independently and does not require assistance nor guidance.
Recommends vetted solutions independently. *
• Thinks strategically within scope. *
• Create drawings for Production and Research and Development *
• Manage projects as a Project Leader within a multidisciplinary project team of peers
independently. Leads other engineers independently. Influences other departments
with guidance. *
• Provide technical support and perform tasks within multidisciplinary project team *
• Document manufacturing and production development process 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 *
• Solve practical problems encountered *
• Document findings and recommendations *
• Create and modify product design specifications *
• If in a supervisory position, select, manage, train, and develop staff. Establish
objectives and assignments and provide ongoing feedback through performance
reviews and development plans. *
• 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
Location and Salary
$125,000 to $175,000
Position Qualifications
Minimum education and experience:
• Bachelor’s degree in engineering or related technical field with 4+ years of
engineering level experience, preferably in the medical device industry, or an
equivalent combination of education and experience
Additional qualifications:
• Master’s degree preferred
• Detailed knowledge of GMP/Quality System Regulations and clean room environment
practices
• Demonstrated knowledge of engineering and scientific principles
• High proficiency with computers and software applications
Working Conditions
• General office, laboratory, and clean room environments.
• Willingness and ability to work on site.
• Business travel from 0% - 10%
• 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.
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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