Technical Project Manager (MLD)

Holistic Partners, Inc; Bothell (WA); On-site; USD 110,000 - 170,000; Full time

Job summary

Holistic Partners, Inc is seeking an experienced Technical Project Manager (MLD) to lead complex program management for medical devices. The role requires coordinating with cross-functional teams, suppliers, and executives to ensure milestones, scope, and quality are met.

This position is based in Bothell, WA and involves both onsite and offshore collaboration. You will maintain integrated schedules, governance, and dashboards, manage risks, and drive delivery metrics while communicating with

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 12+ years of project or program management experience in regulated industries.
• Experience in medical devices and with customer-facing delivery models.
• Experience delivering fixed-price, milestone-based, or outcome-based programs.

Responsibilities

• Serve as onsite single point of contact for program management with stakeholders.
• Develop and maintain integrated work-package and milestone plans aligned with the customer IMS.
• Manage scope, priorities, dependencies, and acceptance criteria across workstreams.
• Maintain Smartsheet dashboards, RAID registers, logs, and forecasts.
• Lead daily coordination, weekly status reviews, monthly governance, and exec reporting.
• Identify and escalate risks related to documentation, access, SME reviews, and schedule.
• Coordinate cross-functional reviews and product closure with controlled-document release.
• Monitor delivery KPIs: on-time delivery, first-pass acceptance, traceability, turnaround, closure.
• Oversee onsite-offshore coordination, capacity planning, backlog readiness, and change control.

Skills

Project management

Stakeholder management

Risk management

Executive reporting

Cross-functional coordination

Education

Bachelor's degree in Engineering/Life Sciences

Tools

Smartsheet

Job description

Job Title: Technical Project Manager (MLD)

Location : Bothell, WA, USA

Duration:: Full-Time/Contract Both

Interview: Virtual

Role and Responsibilities:

• Manage Project (Js onsite single point of contact for program management, functional leads, SMEs, and Steering Committee members.
• Develop and maintain integrated work-package, milestone, resource, and product-wave plans aligned with the customer-owned Integrated Master Schedule.
• Manage scope, priorities, dependencies, deliverables, acceptance criteria, and Definition of Done across multidisciplinary workstreams.
• Maintain Smartsheet dashboards, milestone trackers, RAID registers, decision logs, action trackers, and completion forecasts.
• Lead daily coordination, weekly status reviews, monthly governance meetings, and executive-level reporting.
• Proactively identify and escal risks involving documentation, system access, SME reviews, supplier evidence, V&V records, resources, and schedule.
• Coordinate cross-functional reviews, comment resolution, controlled-document release, milestone acceptance, and product closure.
• Monitor delivery KPIs, including on-time delivery, first-pass acceptance, traceability completion, review turnaround, and action closure.
• Manage onsite-offshore coordination, resource capacity, backlog readiness, knowledge transfer, change control, and customer communication.

Education & Experience:

• Bachelor$B!G(Js degree in Engineering, Life Sciences, or a related discipline.
• At least 12 years of project or program management experience, including experience in medical devices or another regulated industry.
• Proven experience managing customer-facing onsite and offshore delivery models.
• Experience of delivering fixed-price, milestone-based, or outcome-based programs.
• Experience leading multidisciplinary engineering, Quality, Regulatory, Supplier Quality, PMS, and documentation teams.
• Strong knowledge of project planning, milestone management, governance, RAID management, scope control, and executive reporting.
• Understanding of medical-device design controls, DHF remediation, risk management, FMEAs, V&V documentation, and audit readiness.
• Working knowledge of ISO 13485, ISO 14971, FDA quality-system requirements, and EU MDR principles.
• Strong stakeholder management, facilitation, negotiation, communication, and problem-solving skills