Engineering Project Manager

Eliassen Group; St. Louis (MO); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401(k) with company matching

Life insurance

Job summary

Eliassen Group is seeking an experienced Engineering Project Manager for a high-priority capital equipment program in St. Louis. You will drive multiple engineering workstreams, ensure FDA MDR/design controls compliance, and coordinate cross-functional teams including external suppliers.

The role requires an engineering degree, 10+ years in life sciences, and strong Planisware skills. On-site, 6-month contract with potential extension and benefits as part of a w2 engagement.

Qualifications

• Must have 10+ years in Life Sciences with NPD experience in complex medical devices.
• Deep understanding of FDA regulations, MDR, Design Controls and product development processes.
• Experience leading cross-functional teams through regulated product lifecycles.
• Planisware experience for project planning and portfolio management is required.

Responsibilities

• Lead multiple engineering workstreams for a next-generation capital equipment platform.
• Plan and schedule with risk management and execution oversight for assigned workstreams.
• Coordinate with Engineering, R&D, Quality, Regulatory, Manufacturing and external suppliers.
• Develop and maintain detailed project plans, timelines, and resource plans.
• Communicate status to leadership and support governance meetings.

Skills

Project management

Regulatory knowledge

FDA MDR/ Design Controls

Cross-functional leadership

Planisware proficiency

Communication skills

Quality engineering awareness

Education

Bachelor's in Engineering

MBA beneficial

Tools

Planisware

Job description

Engineering Project Manager - New Product Development, Capital Equipment

**this role is fully on-site in St. Louis, MO

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION

Our Global Medical Device Client is seeking an experienced Engineering Project Manager to support one of its highest-priority strategic initiatives: the development of its next-generation capital equipment platform, a premium ophthalmic surgical platform for advanced cataract and retinal procedures.

This critical Engineering Project Manager will join a core program supporting this large-scale new product development program, working alongside other PMs and under a Program Lead, with a direct reporting line into the Asset Strategy Lead.

The individual in this role will be responsible for driving execution of multiple engineering workstreams associated with the platform's accessory portfolio. The right candidate will be a seasoned engineering project manager with deep experience leading complex medical device development programs within FDA-regulated environments.

DUTIES / EXPECTATIONS OF THIS ROLE

• Support execution of a strategic next-generation capital equipment development program by leading workstreams related to product accessories and connected devices. Manage multiple accessory and subsystem workstreams supporting the primary capital equipment platform.
• Lead project planning, scheduling, risk management, and execution for assigned workstreams
• Coordinate cross-functional teams across Engineering, R&D, Quality, Regulatory, Manufacturing, and other key internal stakeholders.
• Coordinate and oversee partnership with external/outside suppliers as needed
• Develop and maintain complex, detailed project plans, timelines, milestones, and resource plans using Planisware.
• Identify project risks, develop mitigation strategies, and proactively communicate project status to leadership.
• Ensure development activities comply with applicable FDA regulations, MDR requirements, and Design Control processes.
• Partner with the Program Manager and Asset Lead to ensure workstreams remain aligned with overall program strategy and product development objectives.
• Track project deliverables, dependencies, and critical path activities throughout the product development lifecycle.
• Support governance meetings and prepare project status updates for leadership.

MUST HAVES - QUALIFICATION SUMMARY

• Bachelor's degree in Engineering. MBA a plus
• Minimum of 10 years of experience within the Life Sciences industry
• Strong engineering foundation with significant experience managing New Product Development (NPD) programs for complex medical devices or capital equipment. Additional experience in Quality Engineering helpful
• Deep understanding of FDA regulations, Medical Device Regulation (MDR), Design Controls, and product development processes.
• Advanced Project Management experience with the ability to manage multiple concurrent workstreams. PE or PMP Desired
• Experience using Planisware for project planning and portfolio management.
• Demonstrated success leading cross-functional engineering project teams through regulated product development lifecycles
• Excellent communication, stakeholder management, and organizational skills.

NICE TO HAVES

• Familiarity with Stage-Gate product development methodologies and portfolio governance
• Experience supporting ophthalmology, surgical capital equipment development programs

TRAVEL & LOCATION

Onsite full-time at our client's facility in St. Louis, MO.

START & TERM

Immediate start. 6-month initial contract term with high likelihood to extend

Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.