Crystal Equation
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Engineer Senior
Top 3 Must Have Skill Sets:
Red Flags:
Summary:
Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Senior Engineer will work closely with team members to develop detailed engineering deliverable timelines, directing and monitoring work efforts on a daily basis, identifying resource needs; and escalating functional, quality, timeline issues appropriately. Responsible for tracking key project milestones and adjusting project plans to meet milestones on time. device design & development, s The qualified candidate will support verification, validation, and regulatory submissions of these devices. Work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
Responsible for driving program execution of various medium to large projects. Individual works with the Program Managers and Project Leaders to ensure that the necessary skills and resources are effectively applied and delivering to plan. This role leads across the Core Team to continuously integrate for predictable execution and teamwork across all functions.
Responsibilities:
Qualifications/Requirements:
Pay range is $38 - $43 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
Engineer Senior
1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Posted: 05/22/2024
2024-05-22
2024-07-20
Job Number: 39213
Job Description
Engineer Senior
Top 3 Must Have Skill Sets:
- Project management, design controls, drug delivery experience, risk based process
- Combination product or medical device development experience.
- Nice to have: Mechanical testing experience.
Red Flags:
- Less than 5 years of experience, jumpy job history
- Not interested in candidates who have not worked in larger organization.
Summary:
Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Senior Engineer will work closely with team members to develop detailed engineering deliverable timelines, directing and monitoring work efforts on a daily basis, identifying resource needs; and escalating functional, quality, timeline issues appropriately. Responsible for tracking key project milestones and adjusting project plans to meet milestones on time. device design & development, s The qualified candidate will support verification, validation, and regulatory submissions of these devices. Work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
Responsible for driving program execution of various medium to large projects. Individual works with the Program Managers and Project Leaders to ensure that the necessary skills and resources are effectively applied and delivering to plan. This role leads across the Core Team to continuously integrate for predictable execution and teamwork across all functions.
Responsibilities:
- Lead medium/small projects independently and work directly with Program Manager on large multi-year programs.
- Managing the overall program including creating and maintaining the project schedule, identifying and mitigating program risks, driving program task execution, and co-leading regular core team meetings.
- Ensures that the product development process abides by all defined cross-functional standards, meets the intent and letter of SOPs and all compliance and regulatory needs of the applicable markets.
- Co-Leads the cross-functional Program Core Team to establish an integrated plan for resources and materials to deliver the new product program per the Product Delivery Team commitment.
- Identifies early and solves complex and ambiguous cross-functional integration problems leading the team to deliver per Product team commitments including (but not limited to) completing functional goals, execution adjustments/iterations, and cross-functional teamwork.
- Works with the Program Manager to ensure effective and efficient communication and execution for the duration of the cross-functional program team.
- Works with the system, subsystem/platform, supply chain, service, QA, RA, Research project leaders to deliver quality products on time, within budget and with the necessary features/functionality.
- Works with the functional engineering leadership team to grow project leadership skills within the Core Team
- Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects. - Provide deep technical assistance for junior engineers.
- Create and maintain project timelines
- Author device documentation to support development, planning, verification, validation, and transfer
- Author test protocols and execute mechanical testing of drug delivery devices
- Presentation and communication skills (within program teams)
- Execute and deliver within regulated development processes
- Proactively maintains close communication with technical leads
Qualifications/Requirements:
- Bachelor's / Master's Degree in Electrical/Mechanical /Biomedical Engineering Computer Engineering or equivalent experience
- Medical device and/or combination product development experience; design controls experience
- 4+ years' experience in project leadership in engineering product development, manufacturing or research environment, including previous leadership of a global and/or virtual team.
- 5+ years of more progressive responsibility and experience as an engineer or scientist
- Demonstrated ability to build lasting cross-functional relationships, including strong influential and communication skills
- Demonstrated understanding/experience with the New Product Introduction (NPI) cycle and cross-functional interdependencies
- MS Project, One Pager, MS Teams, Smartsheet experience a plus
- Doctorate degree
- Master degree and 3 years of experience
- Bachelor degree and 5 years of experience
- Associate degree and 10 years of experience
- High school diploma / GED and 12 years of experience
Pay range is $38 - $43 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
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Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.