- Advance development of robust combination products / drug device combinations for global markets using best Systems Engineering principles
- Advance formal and ad-hoc technical and design reviews for the integrated system
- Spearhead system definition in conformance to global regulatory guidance and best engineering methods including robust design inputs and outputs for clinical and market entry
- Ensure quality through integration of requirements, risks, and implemented mitigations through downstream design outputs
- Drive system verification and validation strategies across platform and brand-specific presentations.
- Own system performance & reliability targets and subsystem allocations
- Provides authorship and expert technical leadership for regulatory filings
- Responsible for mentoring, supervision, and directed professional development of more junior engineersWinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is a leader with these qualifications. Basic Qualifications:
- High School Diploma / GED and 12 years of Engineering experience OR
- Associates Degree and 10 years of Engineering experience OR
- Bachelors Degree and 8 years of Engineering experience OR
- Masters Degree and 6 years of Engineering experience OR
- Doctorate Degree and 2 years of Engineering experiencePreferred Qualifications:
- Masters Degree or PhD in Engineering in mechanical, systems, materials, electrical, or biomedical engineering
- 10+ years of demonstrated success in medical device, drug delivery, or combination product / drug-device combination development for clinical entry and market lifecycle
- 5+ years of demonstrated success leading development of system architecture and design for medical device, drug delivery, or combination products / drug device combinations through product lifecycle
- Prior people management experience
- Demonstrated product design and development success through product launch in major global regulatory regions
- Successful experience managing multiple projects in a deadline driven environment
- Demonstrated strength in development of user needs, market and system requirements, system and process verification and validation strategies, DOE / SPC / Risk Management methods
- Proficiency driving CTQ hierarchical decomposition (flow-down) to subsystems and components
- Strong technical communications, both written and oral at different levels of the business
- INCOSE certification or formal Systems Engineering training/certification
- Strong understanding of injection molding, electronics fabrication, system assembly and manufacturing processes
- Working knowledge of aseptic fill finish and controlled manufacturing environments
- Demonstrated success in platform product development with global multi-generation technology plans
- Robust knowledge of Quality Management Policies and Systems, practical experience in configuration management and change control process/requirements CCB (change control board), CIT (change implementation team) concepts
- Proficient with Production Part Approval Process (PPAP) methodology, documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software
- Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
- Familiar with the following standards: US Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); Needle-based Injection Systems (ISO ; Quality Management (ISO 13485); Risk Management (ISO 14971); EU Medical Device requirements (EU MDR 2021); Medical Electrical Equipment (EN 60601)
- Strong interpersonal skills
- Strong oral and written communication skills.ThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and an annual site shutdown
- Flexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Principal Systems Engineer - Thousand Oaks, United States - Amgen
Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Principal Systems Engineer
Live
What you will do
Lets do this. Lets change the world. The Principal Systems Engineer will ensure the success of multi-functional drug delivery and combination product development efforts through their lifecycle from feasibility through commercial manufacture and lifecycle management. The PSE will work in collaboration with commercial, research, and process development leadership and colleagues to ensure developed product(s) meet the needs of users and meet performance per established requirements. The PSE will lead creation and management of design inputs and outputs including user needs, system requirements, system architecture, and integration of subsystems through clinical entry, market entry, and lifecycle management. This will require ensuring robust systems approach and practices and robust system architecture across the interactions, dependencies, and interfaces of subsystems.
The successful candidate will have demonstrated strength and success in managing interactions with key stakeholders and colleagues in the business.
