Program Manager, Medical Device

Kaye/Bassman International

Marlborough (MA)

On-site

USD 150,000 - 165,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Student loan assistance

Disability insurance

Job summary

A leading innovator in medical device technology is seeking a Program Manager for Medical Devices. This role involves managing cross-functional projects, ensuring compliance with design controls, and driving accountability in project deliverables. The ideal candidate will have extensive experience in program management within the medical device sector, particularly with laser systems. Join a company committed to advancing healthcare outcomes through innovation.

Qualifications

8+ years of Program Management experience in Class II medical devices.
10+ years of technology development experience in laser systems.

Responsibilities

Plans and manages cross-functional projects with external resources.
Monitors project progress and implements corrective actions.
Manages program budgets and tracks actuals against projections.

Skills

Project Management

Risk Management

Communication

Education

MS degree in Engineering

Job description

2 weeks ago Be among the first 25 applicants

Kaye/Bassman International provided pay range

This range is provided by Kaye/Bassman International. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$150,000.00/yr - $165,000.00/yr

Additional compensation types

Annual Bonus and RSUs

Direct message the job poster from Kaye/Bassman International

Experienced Biotech & Pharma & Medical Device Regulatory Affairs & Quality Recruiter | Kaye/Bassman International

Company Overview: Our client is a leading innovator in medical device technology, specializing in advanced laser-powered solutions that enhance patient care. Committed to cutting-edge innovation and excellence, they push the boundaries of medical advancements to improve healthcare outcomes. Join a company where innovation meets purpose and help shape the future of medical technology.

Position: The Program Manager for Medical Devices will play a critical role in planning and directly managing cross-functional projects that may include external resources and contracted companies. This position will partner with the development teams to drive accountability and high-quality project tasks and deliverables.

Responsibilities:

Plans and directly manages cross-functional projects that may include external resources and contracted companies.
Formulates and gains approval for overall project plans in consultation with senior management and stakeholders.
Proactively identify and assess areas of risk, escalate issues promptly, and proactively propose solutions.
Partners with development team members to drive accountability and high quality of project tasks and deliverables.
Continuous prioritization of team member activities and follow-up on actions.
Manages program budgets, generates forecasts, and tracks actuals against projections.
Monitors progress to plan and implement corrective actions or contingencies as needed to maintain commitments.
Provides management with regular project status, plan variances, and corrective action identification.
Works closely with functional management to gain resource commitments and resolve issues.
Provides input to directors/managers and senior management on team member performance.
Effectively manages performance issues and conflicts.
Oversees and facilitates compliance with design control and product development processes.
Ensures project team activities and decisions are clearly communicated and documented.

Ideal Candidate:

MS degree in an Engineering discipline or higher.
Advanced skills in project management, project reporting, and presentations.
8+ years of Program Management experience in one of the following areas: Class II electro-mechanical medical devices, electro-opto-mechanical systems, optics-based medical devices (Laser-based systems, Preferred)
10+ years of technology development experience in one of the following areas: laser systems, electro-opto-mechanical systems, optics-based medical devices.
Track record of executing complex multi-functional projects on time and within budget.
Ability to manage multiple projects in a fast-paced development environment.
Proven experience working within a controlled product development process.
Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred.

Seniority level