Head of Product Development

Department-level leader responsible for overseeing product management, project management, cloud operations, and information security governance for medical device and medical software product lines (hardware, software, Web/Mobile applications). This role manages the department budget, cross-organizational coordination, and both strategic and hands-on execution as needed.

1.Department Management & Budget

A.Lead and manage the product development department. Prepare, evaluate, and allocate departmental budgets, track spending and report to senior leadership.

B.Define department goals, KPIs, resourcing plans, and career development pathways and individual contributors.

C.Drive organizational alignment and coordinate with other departments (R&D, QA/RA, Manufacturing, Sales, IT, Clinical, Finance, Legal).

2.Escalation & Technical/Management Support

A.Act as escalation point for complex technical, project, regulatory, or stakeholder issues that team members cannot resolve.

B.Provide coaching, mentoring, technical guidance, decision support, and conflict resolution to team leads and members.

C.Step in to perform hands-on work (technical execution, troubleshooting, or customer engagement) when required.

3.Scope & Functional Oversight

A.Own departmental scope covering: product management (roadmaps, PRD/SRS), project/program management (schedule, milestones, risk), cloud system operations & maintenance, and information security policy implementation and readiness for internal audits.

B.Ensure product development processes meet regulatory and quality requirements (e.g., ISO 13485, ISO 14971, IEC 62304, IEC 60601, FDA/EU/Local regulations as applicable).

4.Product Portfolio & Sales Enablement

A.Oversee development and lifecycle of medical device hardware, medical device software, and Web/Mobile applications.

B.Software product promotion and sales; participate in pre-sales/technical-sales activities as needed and help shape go-to-market strategy for software offerings.

5.Operations, Compliance & Security

A.Establish and enforce cloud operations best practices (availability, backup, monitoring, incident response) and ensure SOC/security controls are in place.

B.Lead implementation of information security policies, prepare and support internal audits, and ensure compliance with relevant data protection/security requirements.

6.Program Delivery & Continuous Improvement

A.Oversee program delivery, ensuring on-time releases and quality outcomes; manage cross-team dependencies and escalations.

B.Promote continuous improvement (process optimization, automation, DevOps/CI-CD adoption where applicable) and foster a culture of accountability and high performance.

Qualifications & Experience:

1. Work Experience:

(1) 10+ years experience in medical device or regulated healthcare product development, including progressive leadership experience; prior department-level or senior-manager experience strongly preferred.

(2) Demonstrated track record managing multiple teams (product managers, project managers, software engineers, cloud/ops, information security) and delivering regulated products to market.

(3) Experience with cloud system operations (AWS/Azure/GCP), SaaS product lifecycle, and software product sales support or pre-sales activities.

2.Technical Skills:

(1)Regulatory & Quality Knowledge

Practical experience with medical device regulations and standards (FDA 510(k)/PMA, EU MDR, TFDA or equivalent), ISO 13485, ISO 14971, IEC 62304, IEC 60601.

(2)Technical Skills

A.Familiarity with hardware design/manufacturing processes, firmware/embedded systems, and software development lifecycle (Agile, CI/CD concepts).

B.Ability to author technical and regulatory documentation (PRD, SRS, DHF, V&V reports).

C.Experience implementing information security governance and audit readiness; familiarity with data protection regulations and security frameworks.

D.Hands-on capability to perform technical troubleshooting, lead technical deep-dives, and execute critical tasks directly when escalated.

(3)Cross-functional Leadership & Communication

A.Proven ability to coach and mentor managers and engineers, resolve complex cross-functional issues, and make timely decisions under pressure.

B.Proven ability to lead cross-functional teams (R&D, QA/RA, Manufacturing, Clinical, Commercial) and manage external suppliers.

C.Excellent stakeholder management skills and ability to communicate technical and strategic matters to executive leadership.

D.Fluent written and spoken English.

(4)Problem Solving & Risk Management

A.Strong analytical mindset, risk-based thinking, FMEA experience, and track record resolving technical and manufacturing issues.

(5)Business & Sales Acumen

A.Experience in software promotion and sales efforts, including participation in go-to-market planning, customer demos, technical proposals.