Stryker Senior Project Manager, Software R&D in Shirley, Massachusetts
The Airo® TruCT is a visionary product. It boasts the largest inner bore of any 32 slice CT imaging platform currently available for intraoperative use. The Airo is mobile and can be easily driven to and from the OR. The Airo serves to simplify the workflow, enhance usability and enable a medical imaging platform readily available whenever and wherever it’s needed. Our culture is collaborative and passionate. We strive to make the best medical imaging platform available for use in the OR.
Who We Seek:
We are looking for a Goal-oriented orchestrator who can effectively communicate across levels of the organization. This person will be a confident project manager capable of multi-tasking. You will have direct responsibility for driving multiple business critical software projects from concept to implementation. We seek those who will take initiative and proactively engage with stakeholders to ensure project milestones are met. In this role you are an integral part of the Mobius Imaging PMO. Your experience and expertise in Software Project Management will help enable cutting edge new imaging technology as well as sustain existing technologies for improved reliability and customer satisfaction. If you’re a motivated product launcher and driven to make a difference in the lives of our patients, then we need to talk.
We are developing a new high-definition image detector for our Airo® TruCT system. We need a quality-focused team driver to manage the software aspects of our new 64 slice HD detector. In this context you will manage the creation of a software architecture plan, project needs and deliverables as well as a timeline for all aspects of the Airo-HD software development. You will coordinate the software design activities, identify V&V test needs as well as develop a regular cadence of communication for stakeholders.
A key challenge is managing new product development and sustaining engineering initiatives. The Airo® TruCT used in Neurosurgery, Radiation Oncology and Diagnostic Radiology is currently using Windows 7 embedded in its control systems. Given the need for enhanced Cybersecurity we are migrating to a Windows 10 platform. You will have a lead role in migrating the Airo® TruCT to a new operating system. As well, you will be responsible for coordinating and managing the process of deploying critical security updates for Windows 7 in parallel to the Win10 migration program. With software systems at the core of our products, you will always be challenged and in need.
What you will do:
Lead the Product Engineering team’s software projects must have a strong understanding of software design controls and be able to develop an understanding of Stryker’s business and Operations.
Leads software projects in support of new product development activities.
Drives the process around continuous software improvements including bug fix release and OS security updates for the Airo system.
Will be actively engaged in product Cyber security initiatives and projects
Ensure the requirements of 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304 standards are implemented and maintained (including those of all MDSAP countries).
Collaborate cross-functionally with Quality, Regulatory, R&D, Operations and Marketing departments to ensure divisional and operational goals and strategies are met.
Navigates challenging situations by partnering with cross-functional teams to deliver customer satisfaction while ensuring compliance to legal and regulatory requirements
Establish standard processes for consistent project deliverables and provide management oversight of responsible task owners.
Represent design engineering during internal and external audits.
Drives consistent practices throughout all phases of the project life cycle.
What you need:
6+ years of demonstrated technical and professional experience leading software projects in a regulated environment
B.S. in a technical field
PMI certification highly desirable
Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.
Demonstrated leadership skills in either a functional management, project management or technical leadership role.
Demonstrated ability to collaborate effectively with and lead cross-functional teams.
Demonstrated ability to prioritize and manage multiple project workloads.
Ability to Influence across the organization.
Demonstrated process improvement and management skills.
Work From Home: Occasional
Travel Percentage: 10%
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.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com
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