- Manages large and complex projects with full responsibility for project results evidenced by meeting customer expectations of functionality, performance, and quality, while meeting business needs of timing, cost-of-goods-sold, manufacturability, serviceability, and cost of development. Drives NPI projects in cooperation with stakeholders.
- Facilitates communication between people, including internal and external cross functional groups including mechanical and electrical engineering, software development, process development, regulatory, quality, and other teams. Aligns challenging and potentially conflicting needs.
- Effectively communicates strategy, project status, risk mitigation plan, and other business critical information to relevant stakeholders and senior leadership.
- Chairs project milestone reviews collecting feedback from stakeholders compliant with the development process.
- Executes project within the defined requirements (e.g. regarding targets for project cost, time, quality, functionality and customer satisfaction).
- Ensures business success and satisfaction of the customer by professional stakeholder management.
- Works with functional managers to ensure project is staffed appropriately and team members are accountable for assigned deliverables.
- Communicates newly discovered issues quickly and effectively to plan investigations, mitigations, and communicate potential impacts, while leading the effort to eliminate or minimize impact.
- Ensures adherence to architecture, design, quality guidelines as well as product security and product safety topics.
- Manages and ensures compliance to standards, working laws, rules and regulations, intellectual property (IP) freedom to operate.
- Performs risk and opportunity management.
- Performs budget and resource planning as well as generation of project agreement.
- Drives a continuous improvement culture including reuse, cooperation, knowledge management, and lessons learned, among others.
- Drives the identification and protection of project related intellectual property while ensuring alignment with patent and trade secret strategy.
- Ensures completion of appropriate Project documentation in compliance with the design control and development milestone process requirements.
- Incorporates internal and external customer feedback during project execution.
- Identifies team members and team accomplishments deserving recognition for extra-ordinary effort, creativity, collaboration, and results. Celebrates accomplishments.
- Bachelor of Science in Engineering or related field.
- Minimum 10 years of experience as Product Design & Development Manager or Project Management. FDA QSR and EU MDR regulated medical device company preferred.
- Experience in Class II or III medical device preferred.
- Effective Influential and Lead by Example Leadership, Clear Communication, Self-driven Cross-Functional abilities in a global environment is a must.
- Experience with regulatory audits, milestone reviews and presentations
- Strong Product Design, Development, Troubleshooting experience. Working knowledge of CAPA, risk management, hazards analysis, corrections and recalls, defect management, complaint handling and statistical analysis techniques is a plus.
- PMP and other certifications are a plus.
- Up to 25% travel including international.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.
California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here.