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CAIRE

Mechanical Engineering Manager

Saint Paul, MN, United States

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Job details

Experience: 8+ years of progressive mechanical engineering experience, including at least 3 years in medical device or a similarly regulated industry.
Posting language: English

Original job description

Position Summary MGC Diagnostics’ non-invasive cardiorespiratory systems help clinicians measure heart and lung function and make better care decisions. Mechanical design sits at the core: precision airflow and gas sensing, patient-contact components, and durable capital equipment, where every design choice affects accuracy, reliability, and the patient experience. The Mechanical Engineering Manager is a hands-on leader accountable for three pillars of leadership across a portfolio of regulated medical devices:

People Leadership – building, developing, and scaling a high-performing mechanical engineering team
Process Leadership – owning and continuously improving the design and development processes, and serving as the Administrator for the Product Data Management (PDM) system.
Technical Leadership – setting mechanical direction and ensuring high-quality, manufacturable, and compliant designs.

This role sets the standard for how mechanical engineering work is planned, executed, documented, and released. The Mechanical Engineering Manager works very closely with Electrical/Hardware Engineering, Systems Engineering, Industrial Design, Manufacturing Engineering, Quality, and Regulatory partners to deliver integrated product solutions across the full medical device lifecycle. Essential Functions Mechanical Technical Leadership

Set the technical direction for mechanical engineering and lead, and contribute directly to, mechanical design and development across capital equipment, handheld devices, sensors, disposables, patient-contact components, and test fixtures.
Provide technical decision authority for mechanical architecture, materials, tolerancing, and design tradeoffs.
Review and approve mechanical design outputs including:
CAD models and detailed drawings
GD&T and tolerance analyses
Material and component selection
FEA and, as applicable, CFD analyses
DFM/DFA and design-for-serviceability considerations
Drive mechanical integration at the system level in close collaboration with Electrical/Hardware, Systems, Software/Firmware, and Industrial Design teams.
Partner with Systems Engineering on verification and validation, providing mechanical expertise on test methods, fixtures, and review of results.
Serve as the escalation point for complex or high-risk mechanical design challenges.

People Leadership & Team Development

Lead and manage a growing team of mechanical engineers, overseeing recruitment and selection recommendations, onboarding, performance management, employee development, and workforce planning in alignment with MGC Diagnostics’ approval processes.
Mentor and develop engineers to build technical depth, engineering judgment, and problem-solving capability.
Set priorities, allocate resources, and ensure alignment with program schedules and business objectives.
Conduct regular 1:1s, performance reviews, and development planning.
Lead succession planning and talent development to support long-term organizational growth.
Foster a culture of accountability, technical rigor, collaboration, and continuous improvement.
Track departmental and project performance through established KPIs and prepare regular status reports for leadership and key stakeholders.

Engineering Process Leadership & PDM Administration

Serve as the Administrator for the SolidWorks PDM system, owning vault configuration, workflows, states and transitions, user roles and permissions, data cards, templates, and revision schemes.
Maintain PDM data integrity, backups, upgrades, and access control in partnership with IT, and ensure PDM workflows align with document control, change control, and quality system requirements.
Lead PDM user training, onboarding, and support, and serve as the escalation point for PDM issues.
Own and drive continuous improvement of mechanical design and development processes, including:
CAD, drawing, and GD&T standards and best practices
Design review, release, and engineering change processes
Part numbering, BOM structure, and PDM-to-ERP data handoff
Design control templates, work instructions, and SOPs related to mechanical engineering
Identify process bottlenecks and lead improvement initiatives that reduce cycle time, rework, and late-stage design changes.
Define and track process metrics, and lead change management so that new tools, standards, and processes are adopted across Engineering and partner functions.

Program & Cross-Functional Leadership

Own mechanical engineering deliverables across product development programs.
Provide program-level leadership for mechanical execution, including schedule commitments and risk management.
Represent mechanical engineering in:
Design reviews
Risk management reviews
Cross-functional technical forums
Own the mechanical design side of sustaining engineering, including design changes, component obsolescence, cost reduction, and complaint and CAPA investigations with a mechanical root cause.
Partner with Manufacturing Engineering on design transfer and production issues, providing mechanical design expertise to resolve problems at their source.
Drive early identification and mitigation of mechanical risks to minimize late-stage changes and manufacturing escapes.
Direct external vendors, suppliers, and tooling partners and hold them accountable for technical deliverables.

Quality & Regulatory Compliance

Serve as the mechanical subject-matter expert for internal and external audits and regulatory interactions as needed, in partnership with Quality and Regulatory teams.
Lead mechanical engineering activities through all phases of the medical device lifecycle within a regulated environment (FDA, ISO 13485, ISO 14971, IEC standards).
Review and approve design control documentation, including:
Design inputs and outputs
Risk management files
Verification and validation documentation
Ensure mechanical engineering activities comply with internal SOPs and quality system requirements.
Bring new materials, manufacturing methods, and design tools into the team’s practice, staying current on engineering and scientific developments relevant to company products.

MGC Diagnostics provides reasonable accommodations to qualified applicants and employees with disabilities and to applicants and employees with known limitations related to pregnancy, childbirth, or related medical conditions, as required by applicable law. Supervisory Responsibility Directly supervises the Mechanical Engineering team, including hiring, performance management, and career development. Provides process leadership to engineering users of the PDM system across functions. Work Environment This role operates in a hybrid work environment, combining office-based work with regular on-site presence in engineering laboratories, fabrication areas, and production/manufacturing environments. On-site work is required to support hands-on design reviews, prototype builds, testing activities, and cross-functional collaboration. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Occasional crouching, kneeling, or working in confined areas when inspecting, installing, or troubleshooting equipment.
Occasional lifting and carrying of equipment or materials weighing up to 50 pounds, with or without reasonable accommodation.
Occasional pushing, pulling and handling of materials.

Travel Travel: Up to 10%, including occasional travel to suppliers, contract manufacturers, test laboratories, or other company locations. Required Education and Experience

Bachelor’s degree in Mechanical Engineering or a related discipline.
8+ years of progressive mechanical engineering experience, including at least 3 years in medical device or a similarly regulated industry.
Proven people-management track record: 3+ years directly managing engineers, including hiring, performance management, mentoring, and career development.
Expert proficiency in SolidWorks 3D CAD and experience across injection molding, sheet metal fabrication, machining, welding, and additive manufacturing.
Experience with SolidWorks PDM or an equivalent PDM/PLM system; administration experience strongly preferred.
Strong command of GD&T and tolerance stack-up analysis.
Working knowledge of FEA sufficient to direct, review, and challenge the work of engineers performing analyses.
Working knowledge of design controls (21 CFR 820 / ISO 13485) and risk management (ISO 14971).
Proven ability to define, document, and improve engineering processes and standards in a regulated environment.

Preferred Education and Experience Ideal candidates will also bring experience contributing to verification and validation, including test methods and fixtures; managing engineering change control, BOM structure, and configuration management; owning engineering deliverables, schedules, and technical risks within product development programs; and directing suppliers and tooling partners, including injection mold tool development. We also value CFD experience, patient-contact or human-factors-sensitive design experience, and a track record of leading process improvement (e.g., Lean, Six Sigma). We’re looking for a leader who communicates clearly with senior leadership and thrives in cross-functional, systems-driven teams. Credentials that strengthen a candidacy include SolidWorks PDM Administration certification or equivalent training, a Professional Engineer (PE) license, or a Master’s degree in Mechanical Engineering or a related field. Additional Eligibility Qualifications None required for this position. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. MGC Diagnostics is an equal opportunity employer. Employment decisions are made without regard to race, color, creed, religion, national origin, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity, marital status, familial status, status with regard to public assistance, membership or activity in a local human-rights commission, age, disability, genetic information, veteran or military status, or any other status protected by applicable federal, state, or local law. MGC Diagnostics also prohibits retaliation against individuals who engage in legally protected activity and provides reasonable accommodations as required by applicable law.

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More about this job

Skills

Mechanical engineering
Leadership
Product data management
Industrial design
FEA
CFD
Collaboration
Firmware
Team building
Recruitment
Onboarding
Performance management
Problem solving
Process improvement
Dassault Systemes SolidWorks
ERP
Change management
Risk management
Regulatory compliance
Documentation
Troubleshooting
Team leadership
Coaching
Machining
Welding
PLM
Engineering processes
Lean manufacturing
P.Eng.

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Jobs in the United States