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As a Project Specialist, you will play an integral part in Penumbra's manufacturing process. You will participates in cross-functional planning, development and implementation of eDHR (electronic DHR) in Production and Quality. As Subject Matter Expert (SME), the position will work with personnel in the Production area to ensure that they have the knowledge and tools to perform daily system activities. Knowledge of Quality Systems, Camstar and production processes will lead to positive outcomes for users of the system during launches and system upgrades.
What You'll Work On:
• Support eDHR implementation rollout strategy participating on a cross-functional team. Lead an execution team in generating, developing and testing workflow solutions as part of the line specific executions.
• Use experience with computers, software systems and eDHR to make good decisions when solving difficult problems identified during line executions and issue investigations with little guidance.
• Lead brainstorming and process mapping sessions as part of eDHR workflow development.
• Use SME level knowledge of existing operations tools, systems and production processes to participate in system development, workflow modeling as well as identify opportunities for improvement.
• Use substantial working knowledge of Quality System requirements to ensure line compliance before/after execution.
• Communicate issues and needs from users to system support and development teams. Provide creative solutions to problems
• Coach and train system users and new eDHR facilitators on day-to-day use of eDHR.
• Provide onsite support on both shifts during eDHR executions, as needed.
• Maintain a Safe and Compliant work environment
o Ensure that health and safety guidelines are followed at all times
What You Bring:
• A Bachelor’s degree with 2+ years Operations experience in a medical device or regulated industry, or equivalent combination of education and experience
• Ability to analyze the production processes and identify gaps
• Excellent oral, written, interpersonal and teamwork skills required
• Strong attention to detail
• Strong proficiency with MS Word, Excel and Power Point
Working Conditions:
General office and cleanroom environments. Willingness and ability to work on site at least 3 days a week. May have business travel from 5% - 15%; travel 1-2 days a month as needed. 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. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Annual Base Salary Range: $71,000 - $102,000/yearly
We offer a competitive compensation package plus a benefits and equity program, when applicable.
Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
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.
Top Skills
What We Do
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.
Members of the Penumbra team agree that this is where their work has meaning -- we are transforming the treatment of some of the world's most devastating conditions. Penumbra is where everyone's ideas matter, and where learning and growth are constant.
