Principal Manufacturing Engineer

Principal Manufacturing Engineer – Medical Device New Product Development

Are you ready to take the next step in a career that’s both challenging and deeply rewarding? Your skills in the following areas will make you an ideal candidate for this role -
Hardware (console) manufacturing of a FDA regulated medical device and/or an in-depth knowledge of complex medical device injection molding and plastic joining techniques (ultrasonic/RF/laser welding, adhesive bonding.) A background in automation, high mix/low volume, the ability to anticipate roadblocks and provide a high level of team leadership.

Our client, located in the Greater Boston area, is a commercial-stage medical device company transforming transplant care through advanced technology that increases access to viable donor organs. Their innovations have dramatically improved patient survival and recovery—and they’re just getting started.They are hiring a Principal Manufacturing Engineer – NPI to lead new product introduction and scale high-impact technology that supports clinical care, service excellence, and life-saving outcomes. This role is ideal for a strategic, hands-on engineer who thrives in fast-paced, mission-driven environments.
RESPONSIBILITIES:

This position is responsible for, but not limited to, the following:

• Serve as the technical project leader for NPI manufacturing activities, driving the development and commercialization of products.
• Provide strategic oversight of manufacturing readiness for new product introductions, ensuring alignment of engineering resources, project schedules, and cross-functional deliverables.
• Lead cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, and Manufacturing Operations to ensure robust, scalable, and compliant processes.
• Coordinate, identify, and implement advanced manufacturing processes to ensure production capacity, efficiency, cost-effectiveness, and adherence to quality standards.
• Define project plans, timelines, and resources needed to support NPI manufacturing programs, ensuring accountability for milestones and deliverables.
• Apply in-depth technical expertise to specify, design, and validate equipment, tooling, fixtures, and automation used in production.
• Drive PFMEA, DFM/DFA, and design transfer activities to establish capable, efficient, and risk-mitigated manufacturing processes.
• Develop manufacturing assembly and test methods that ensure Critical to Quality (CTQ) and Critical to Assembly (CTA) requirements are met.
• Establish and track Key Performance Indicators (KPIs) and process capability metrics using statistical tools such as MSA, GR&R, and SPC.
• Represent externally and internally as a manufacturing subject matter expert (SME), ensuring effective knowledge transfer to production and suppliers.
• Mentor and guide junior engineers and technical staff, fostering a culture of engineering rigor, accountability, and innovation.
• Perform other tasks and duties as assigned/required.

MINIMUM QUALIFICATIONS:

• BS in Mechanical Engineering or related engineering discipline required.
• 10+ years of experience in an FDA/ISO-regulated medical device or medical equipment manufacturing environment.
• Are you ready to take the next step in a career that’s both challenging and deeply rewarding? If you have a background with
• Proven leadership in the selection, qualification, and scale-up of capital assembly equipment and automation.

PREFERRED QUALIFICATIONS:

• Advanced degree preferred.
• Demonstrated expertise in automated assembly methods, robotics, automated inspection, and fixture/tooling design.
• Strong knowledge of injection molding and plastic joining techniques (ultrasonic/RF/laser welding, adhesive/solvent bonding).
• Proficiency in SolidWorks for 3D modeling and design of assembly models, fixtures, and tooling.
• Lean Six Sigma experience and proficiency in statistical data analysis tools (Minitab or equivalent) strongly preferred.
• Strong project management skills, with demonstrated accountability for planning, execution, and delivery of NPI milestones.
• Exceptional leadership and interpersonal skills, with ability to influence and align cross-functional teams.
• Excellent verbal and written communication skills, with the ability to present technical and project information to leadership and stakeholders.
• Proven ability to thrive in a fast-paced, dynamic environment, with adaptability to shifting priorities.
• Ability to work independently with high competency, while also driving and coordinating team-based execution.

Employee Benefits:

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan

Relocation available – only US Citizens or Green Card holders will be considered. Candidates must have Medical Device/Medical Equipment experience to be considered.

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