Senior Project Manager, R&D

Description

The company develops healthcare products across medicines and medical technology, aiming to prevent, treat and cure complex diseases with smarter, less invasive and more personal solutions.

The orthopaedics team builds joint reconstruction, trauma and craniomaxillofacial, sports, extremities, foot and ankle, spine, and robotics and digital surgery solutions, helping more than 6 million people stay mobile each year while providing clinical and economic value to surgeons and health systems.

This role sits in the Trauma business and leads development of orthopedic devices, including implants, instruments, and related hardware and software. It includes bringing Software as a Medical Device (SaMD) capabilities into orthopedic product programs.

The orthopaedics business is being separated into a standalone company, expected within 18 to 24 months, subject to legal requirements, works council and employee representative consultation where required, regulatory approvals and other customary conditions. If you accept, you would likely become an employee of that standalone company after the transaction, under its employment processes, policies and benefit plans. The company would share details of any planned changes at an appropriate time and after any necessary consultation.

The role is in the Project/Program Management Group, within R&D Project Management, at the Professional level, based in West Chester, Pennsylvania, USA.

Responsibilities

• Bring hardware, software, systems and cross-functional work into one project plan, planning and tracking dependencies, verification and validation, regulatory deliverables and launch requirements.
• Lead complex cross-functional new product development projects through several phases of the development lifecycle, from initiation to product launch.
• Own and maintain the integrated project plan, covering milestones, dependencies, critical path, resources, risks and key deliverables.
• Drive delivery against scope, schedule, budget, resources and business commitments.
• Lead cross-functional teams in a matrixed setting, setting clear ownership, accountability, priorities and timing.
• Spot project risks, issues, schedule impacts, resource gaps and dependencies early, and lead mitigation or recovery plans.
• Coordinate work across R&D and Engineering, Quality, Regulatory, Manufacturing and Operations, Supply Chain, Clinical, Marketing and other functions.
• Make sure plans include design controls, risk management, verification and validation, regulatory work, manufacturing readiness, design transfer and launch activities.
• Drive alignment across functions, run trade-off discussions, support decisions and resolve issues.
• Set up effective project governance and keep project documentation current.
• Give clear, concise updates to project teams and leadership on overall health, milestones, critical path, risks, issues, decisions and required actions.
• Escalate significant risks and issues with a clear view of likely impact and recommended actions.
• Make sure work follows company policies, procedures, quality standards and regulatory requirements.
• Take on other duties as assigned.

Requirements

• Bachelor's degree in Engineering, Science, Business or a related field.
• 4-6+ years of increasingly responsible project or program management, including complex product development.
• Proven experience leading cross-functional teams in a regulated product development setting.
• Proven experience building and running integrated schedules with cross-functional dependencies, milestones and critical-path activities.
• Experience taking projects through several phases of the product development lifecycle.
• Strong skills in managing project risks, issues, dependencies and schedules.
• Proven ability to lead and influence cross-functional teams in a matrixed organization without direct authority.
• Strong written, verbal, presentation and leadership communication skills.
• Ability to understand technical information and turn it into project implications, risks, dependencies and actions.
• Preferred: advanced technical or business degree.
• Preferred: PMP certification, or willingness to obtain it.
• Preferred: experience leading new product development programs involving Software as a Medical Device (SaMD), connected medical devices, or software-enabled medical device products.
• Strongly preferred: medical device industry experience.
• Strongly preferred: orthopedic medical device experience, particularly Trauma, implants, fixation systems, surgical instruments or related hardware.
• Preferred: experience with medical device design controls and structured new product development processes.
• Preferred: experience taking products through verification and validation, design transfer, manufacturing readiness and commercial launch.
• Preferred: experience with globally distributed project teams.

Conditions

Hybrid role based in West Chester, Pennsylvania, USA.

Anticipated base pay range is $92,000.00 - $148,350.00.

Equal opportunity employer; accommodations are available during the interview process on request.

Benefits

• Eligible for the company's consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year; 48 hours per calendar year for Colorado residents; 56 hours per calendar year for Washington residents.
• Holiday pay, including floating holidays: 13 days per calendar year.
• Work, personal and family time: up to 40 hours per calendar year.
• Parental leave: 480 hours within one year of the birth, adoption or foster care of a child.
• Bereavement leave: 240 hours for an immediate family member; 40 hours for an extended family member, per calendar year.
• Caregiver leave: 80 hours in a 52-week rolling period, 10 days.
• Volunteer leave: 32 hours per calendar year.
• Military spouse time-off: 80 hours per calendar year.
• Time-off eligibility depends on the applicable policy and date of hire.