Software Product Manager

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Job Description

Your role at Takeda:

Our Connected Software Medical Device development team (CSMD) within Takeda’s Drug Products and Device Development – Pharmaceutical Sciences organization is looking for an experienced Software as a Medical Device (SaMD) Product Manager who will be responsible for R&D SaMD pipeline development programs and global lifecycle management commercial support post-launch. As a SaMD R&D Product Manager, you will lead product development with a supporting cross functional SaMD core team ensuring that the project plan, budget, and global compliance objectives are met.  As part of our CSMD team, you will be a critical part of SaMD development and the global product team (GPT) pharmaceutical sciences project reporting process.

Your top-level contributions:

Under the direction of the Lead, Connected and Software Medical Devices, the Product Manager will develop a product strategy and roadmap of software-focused products in the portfolio.  This position will be responsible for end-to-end product vision, development, execution, localization up to and including coordinating with commercialization and uptake associated with product management activities.  They would work with software developers, testers, project managers, and commercial teams to deliver on the product vision.  They will manage stakeholders and lead cross-functional teams aligning on timely delivery of products.

As a hands-on technical and digital health expert, this person will assist in work efforts through feasibility, development, qualification, launch, and post-market life cycle phases of device development.  Areas of focus will include assisting with the project plan, user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, development oversight, design outputs, country localization, market launch, and post-market release management activities.  The role includes extensive collaboration with internal and external partners.

This individual is expected to participate in various areas of software device development (e.g. design control, change control, device regulatory strategy, etc.) and have software technical knowledge to assist in the identification and assessment of new/emerging technologies with potential application to Takeda products.

This individual is expected to demonstrate solid delivery of commitments while working within agreed upon timelines. To that end, solid project management, organization, and communication skills are needed to drive projects to completion and to effectively communicate progress along the way.

The Product Manager should be a software enthusiast who is excited and eager to bring digital tools such as mobile apps, web tools, and connected medical devices into the hands of Takeda’s patients. They should be eager to learn about the daily lives of the patients who rely on Takeda therapies and how we can better serve these patients with innovative tools.

DIMENSIONS AND ASPECTS:

Connected & Software Medical Device Project Execution:

• Responsible for assisting in device design inputs and design outputs; verification / validation testing, delivery, and post market support.

• Assist in delivery of device implementations on time and within budget

• Act as a subject matter technical expert in connected health industry technology including and not limited to mobile and web technology.

• Provide input to develop Takeda’s digital health technical platforms and capabilities.

• Ensure thorough documentation throughout all phases of the software development lifecycle.

• Work effectively in cross-functional teams consisting of Clinical, Design & Usability, Marketing, Privacy, Security, Quality, and Regulatory     

Vendor Engagement:

• Assist in vendor management e.g. software developers, localization companies, backend/DevOps support.

• Assist in vendor assessments

• Develop and maintain inclusive collaboration across functions and across global and local region / country teams.

Connected & Software Medical Device Post-Market Surveillance Activities:

• Assist in responding to post market surveillance issues such as product complaints and issues

• Assist in audit / inspection actions.

• Assist in documenting compliance requirements in changing regulatory and data privacy impacts to devices.

Connected & Software Medical Device Technology Planning / Assessment:

• Provide input into the assessment of technologies as part of the long-range device plans, and products and services aligned with establish global connected health solutions for our products around the world.

• Identify and document scope and requirements for specific products (e.g., user stories, use cases, user segments).

• Develop stakeholder relationships to gather input into device product or platform projects.

Minimum Requirements/Qualifications:

• BS/BEng in a technically relevant field of study (e.g. Computer Science, Biomedical Engineering, Information Technology, Computer Engineering) with minimum five (5) years’ experience in product or software development and delivery. Non-technical education background can be considered with enough recent software/healthcare experience.

• Experience with digital or software product development

• Prior experience as a software developer is not required but should have a good understanding of how software is developed and brought to the market (e.g. programming languages/technologies, mobile apps, embedded software, web and data technologies). The candidate will be expected to be able to work closely with technical teams and to be able to understand software technology and development methodologies.

• Exposure to performing technology assessments, typically supporting due diligence activities.

• Understanding of research and development lifecycle and/or commercialization of medical devices, including combination products and connected drug delivery systems

• Experience in developing and maintaining cross-functional relationships

• Excellent written and oral communication skills

• Understands how user needs drive technical requirements

• Self-starter – Needs to be eager to learn about new and existing projects and run with them. Should be able to drive software projects as a key team leader with minimal need for oversight.

• Good project management skills – ability to track scope, scope creep, manage project risks, and communicate timely progress updates

Preferred Qualifications:

• Awareness of medical device global regulations and standards e.g. IEC 63204, ISO 13485, ISO 14971, Design Control - CFR 820.30

• Knowledge of agile methodologies, especially scrum – Knowledge of scrum ceremonies, roles, and tracking techniques. Skills at developing business cases, ROI analysis, and value propositions

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

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U.S. Base Salary Range:

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Job Exempt