Program Manager, MDR Labeling
Redmond, WA

Job Description

Job Description

Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Program Manager, MDR Labeling to join our Medical Division to be located in Redmond, WA.

Who we want

* Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
* Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success.
* Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
* Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As the Program Manager, MDR Labeling, you will be responsible for managing the labeling process within Stryker Medical based out of Redmond and lead the labeling changes required for the European Medical Device Regulation (EU MDR). You will direct other labeling Project Engineers/Project Managers to support the execution of labeling projects for new and sustaining engineering that intersect with EU MDR. You will be required to interface with many cross-functional stakeholders to develop the appropriate timelines and ensure the assembled teams can successfully execute the EU MDR labeling program.

* Create, maintain and communicate appropriate program documentation (e.g. charter, roadmap, benefits map, etc.) to meet business goals and program objectives.
* Responsible for labeling change management, including change project plans, change orders, and design reviews as needed
* Document owner for the labeling procedures and responsible to drive continuous improvement
* Ensure products are labeled in accordance with global regulatory requirements
* Responsible for program budget estimation, monitoring, and attainment.
* Create and maintain a program risk assessment to ensure program risks are identified and closed.
* Responsible for portfolio resource planning including workload allocation and capacity planning to help determine project sequencing in the program.
* Work with constituent project managers or associates to monitor cost, schedule, and technical performance of component projects and operations, while working to ensure the ultimate success of the organization's business objectives.
* Assess trade-offs for changes to project scope, schedule, and costs that impact the program and related projects.
* Responsible for team performance by building team cohesiveness, leading, influencing, training, mentoring, and motivating.
* Act as an escalation point, drives collaboration with program and project team members to resolve conflicts, project issues, and deviations to drive them to resolution.
* May be responsible for managing project managers and project personnel, as well as leading indirect resources.

What you need

* A minimum of a Bachelor's Degree (B.S. or B.A.) required; emphasis in management or related discipline preferred.
* A minimum of 9 years of experience in an FDA regulated industry required.
* A minimum of 2 years in a project management role required.
* A Master's Degree or advance degree preferred.
* PMP certification or equivalent (i.e. PRINCE2) preferred.
* Experience in design control and change control required.
* Product labeling requirements in the medical device industry including knowledge of FDA, ISO, and EN labeling requirements preferred.
* Experience with lean/six sigma process improvements preferred.
* Experienced in launching new or updated products, redesigns, line extensions or maintenance items in a medical device, food, or pharma company preferred.
* Knowledge of EU MDR requirements preferred.
* Experience with project management systems (e.g. Microsoft Project) preferred.
* Demonstrated versatility and a willingness to manage and lead a team through change and ambiguity.
* Strong interpersonal skills required in the areas of verbal and written communications, customer focus, time management, professionalism, coaching, influencing, and team building.
* Ability to build trusting relationships with midlevel management and presenting proposals to executives.
* Ability to generate and explain opportunity analysis and value assessments accurately.
* Demonstrated ability to mentor, train, and develop direct and indirect team members.
* Strong problem-solving skills; ability to identify and execute effective solutions.
* Excellent organizational and time management skills.
* Proficient in the use of a personal computer with experience in Microsoft Word, Excel, Power Point, Microsoft Project, network systems (electronic mail) and Internet applications.

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.