Solution Leader, Werfen ActiveConnect

Werfen • Bedford, MA

6h • $160,000 - $195,000

About The Position

Werfen is hiring a Solution Leader to own Werfen ActiveConnect, its cloud-based connected-service platform for Hemostasis, Acute Care and Autoimmunity analyzers. Built as a multi-tenant SaaS product on AWS, ActiveConnect connects customer laboratory instruments to Werfen’s global service organization through an on-premise gateway, enabling secure remote access, remote software delivery and retrieval of instrument logs. The platform is moving from its first controlled release into deployment across product lines and regions. This is an end-to-end product-ownership role accountable for product vision and roadmap, releases, launch and adoption across affiliates, and transition to a governed, scalable operation.

The Solution Leader will work across Digital Factory engineering, business-unit R&D and Quality/Regulatory, Global Service and Support, commercial affiliates, IT, Cybersecurity and the Global Privacy Office. The role reports to the Expert Solution Leader, Cloud Platforms. Success includes owning the backlog and release plan, establishing a prioritized roadmap and decision rights, achieving stable deployment across multiple instrument families and regions, and making adoption and service value measurable.

Requirements

• Bachelor’s degree in Biological Science, Engineering or Business Administration, or equivalent.
• 3–5 years of relevant work experience; healthcare industry experience is preferred.
• Strong communication and collaboration skills across technical and business stakeholders and cross-functional teams.
• Strong problem-solving, leadership and individual-contributor capabilities.
• Proven knowledge of standard concepts, practices and procedures in the relevant industry.
• Experience with B2C digital products.
• Understanding of roles in regulated industries and how they interact with product offerings.
• Up to 15% travel.

Nice To Haves

• Hands-on software product-management experience writing requirements, user stories and acceptance criteria; leading backlog refinement and sprint planning; and taking software changes through controlled change and release processes.
• Experience leading without authority in a global matrix involving international affiliates or regional business units.
• Experience releasing software in a regulated environment, preferably medical devices or in vitro diagnostics, under IEC 62304, ISO 13485 or equivalent design controls.
• Working knowledge of cloud-hosted products, preferably AWS, and networking and security concepts relevant to hospital IT.
• Practical understanding of healthcare data protection and cybersecurity expectations, including HIPAA, GDPR and FDA premarket cybersecurity guidance.
• Hands-on experience deploying virtualized infrastructure, such as VMware vSphere/ESXi or Hyper-V virtual appliances, in customer or hospital networks, including network, firewall and certificate configuration.
• Experience with field-service organizations, service operations or remote-service platforms for capital equipment.
• Familiarity with clinical laboratory workflows and laboratory instrument connectivity.
• MBA or equivalent business training.
• At least two years of relevant agile and Scrum experience.
• Experience facilitating agile ceremonies, managing a backlog and release plan, tracking team-level metrics and removing blockers.
• Experience leading teams, preferably in an agile setting.
• Understanding of laboratory and clinical workflows as they relate to diagnostics.

Responsibilities

• Own the ActiveConnect product vision and multi-release roadmap; prioritize the backlog across business units, affiliates and service needs, and maintain a clear source of truth for decisions and priorities.
• Translate customer and field-service needs into clear, testable requirements in collaboration with Scrum teams, architects and business analysts.
• Own the compatibility matrix for supported instrument and middleware software versions, and coordinate ActiveConnect releases with business-unit release schedules.
• Break approved requirements into user stories and technical tasks with testable acceptance criteria; lead backlog refinement and sprint planning, keep work refined at least one sprint ahead, and set sprint goals aligned with the release plan.
• Track sprint and release progress, communicate feature completion, scope changes, delivery risks and delays, and recommend actions to stakeholders and leadership.
• Ensure requirements are traced to verification; review verification results and anomalies with engineering and QA; lead product-level validation with service and affiliate users; and confirm release readiness and documentation completeness.
• Lead the product’s contributions to software lifecycle design controls under IEC 62304 and ISO 13485, including requirements, risk-management contributions, release documentation, labeling, and the cybersecurity and privacy guide.
• Partner with Cybersecurity, GRC and the Global Privacy Office to define and meet security, privacy and data-protection requirements for releases and new territories.
• Prepare affiliates to support hospital IT and security reviews, including network and connectivity requirements, security questionnaires and installation-authorization documentation.
• Establish relationships with affiliate champions and business-unit counterparts, and support deployment, rollout, adoption and measurable service value.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan with employer match
• Paid vacation
• Paid sick leave
• Performance-based bonus eligibility for management and select professional roles

What This Job Offers

• Job Type: Full-time
• Career Level: Senior