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Company | Boston Scientific |
Address | Maple Grove, MN, United States |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing |
Expires | 2023-07-10 |
Posted at | 11 months ago |
Additional Location(s): US-MN-Maple Grove
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About The Role
Manages the development of Clinical Product Risk deliverables for PI portfolio including deliverables for sustaining, MDR, and new product development (NPD). Strategizes and plans so that Clinical Product Risk work cadence aligns with Quality System requirements, PSUR cadence, MDR or NPD submissions, new regulations, and other requirements. Supports Core Teams by maintaining responsibility for Clinical Product Risk deliverables. Has working knowledge of resources needed for Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) activities. Collaborates with Clinical Product Risk management/leadership, Clinical Product Risk team members, cross-functional partners, and cross-divisional partners as needed.
Your Responsibilities Will Include
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About The Role
Manages the development of Clinical Product Risk deliverables for PI portfolio including deliverables for sustaining, MDR, and new product development (NPD). Strategizes and plans so that Clinical Product Risk work cadence aligns with Quality System requirements, PSUR cadence, MDR or NPD submissions, new regulations, and other requirements. Supports Core Teams by maintaining responsibility for Clinical Product Risk deliverables. Has working knowledge of resources needed for Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) activities. Collaborates with Clinical Product Risk management/leadership, Clinical Product Risk team members, cross-functional partners, and cross-divisional partners as needed.
Your Responsibilities Will Include
- Monitoring the execution of ongoing projects
- Identifies resourcing bottlenecks and provides solutions.
- Builds and maintains the schedule of work for PI Clinical Product Risk deliverables, including CEPs and CERs, PMCF activities, and PMCF Plans and Reports.
- Helps develop and implement divisional/team best practices and collaborates with cross divisional counterparts/partners to share best practices.
- Directs project execution by working with management to assign tasks, track project schedules, identify risks, and develop and execute (with agreement from Clinical Product Risk management) contingency plans.
- Conceptualize and implement efficiencies to support Clinical Product Risk team and ensure team is operating at the highest operational level.
- Process improvement: assessing impact of global procedural changes; seeks opportunities for efficiency gains; identifies recurring challenges/issues and proposes solutions
- Management of schedule and resourcing for projects
- Identifies and resolves project issues by collaborating with team members and cross-functional partners/teams others as appropriate.
- Participates in external project management organizations, conferences and seminars to keep current with industry best practices in project management by joining professional associations and implementing a professional development plan with focus on project management.
- Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by collaborating with appropriate staff to understand scope of effort.
- Communicates project status by preparing standard status reports, providing quarterly metrics to Clinical Product Risk management, and participates in departmental project status update meetings and divisional meetings as needed.
- Supports Regulatory/Clinical strategies as a Clinical Product Risk Functional Representative and aligns Clinical Product Risk strategy to that of cross-functional partners, ensuring timelines are met, including those related to PSUR cadence, periodic updates, submissions.
- Prepares project plans, schedules, and develops metrics by using project management tools such as Microsoft Project and by collaborating with appropriate staff to understand tasks necessary to complete project.
- Clinical Evaluation and Project Management experience
- Interacting with stakeholders and business colleagues to analyze and define business requirements and related project reporting, developing methodologies to create and enhance applications and tools
- Ability to present to senior levels within the organization
- 5-8 years with bachelor’s degree, or an equivalent combination of education/work experience
- Strong technical skills with Excel and MS Project
- Excellent verbal and written communication skills
- Excellent problem solving and analytical skills, attention-to-detail
- Ability to influence change to bring forward Learning opportunities across the organization
- PMP Certification
- Clinical or Financial planning systems experience
- Ability to lead in a collaborative manner
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code
- 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
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