Sr. Manager, Advanced Manufacturing Engineering

MicroAire Surgical Instruments LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

Leads Advanced Manufacturing initiatives across supply chain, sustaining engineering, manufacturing engineering, and process development for existing and new mechanical and electromechanical products. Serves as a technical advisor in researching and implementing manufacturing technology and is responsible for assigned elements of new product development under MicroAire Design Controls Procedures. Manages the technical and personnel aspects of facilities maintenance and provides technical leadership in areas critical to MicroAire’s success.

+ Essential Duties and Responsibilities

• Drives the planning and execution of critical Advanced Manufacturing projects for insourcing, automation, and continuous improvement, including cost savings, delivery, and quality.

• Leads or coaches critical continuous improvement, Lean, kaizen, and Blue Belt projects. Coordinates corporate CI tracking and planning, drives the site CI calendar, and tracks and reports savings.

• Supports Supply Chain in the technical aspects of insourcing, alternative sourcing, supplier quality, and supplier continuous improvement. Supports business initiatives such as repairs and service programs.

• Participates and makes recommendations regarding departmental quarterly plans and performs all essential duties and responsibilities within the company’s mission, vision and values.

• Develops career paths for direct reports.

• Provides guidance to manufacturing engineering for new highly critical products and oversees facilities maintenance activities within cross-functional teams consistent with departmental goals and objectives.

• Oversees Engineering activity around investigation and root cause analysis for failures observed in the field that needs Engineering support.

• Serves as the specialized technical expert resource for all project teams for manufacturing engineering projects.

• Provides leadership by taking initiative for existing product modifications.

• Provides guidance on Design For Manufacturing during New Product Development process.

• Interfaces with all departments within the company as well as consultants, vendors, surgeons, and others as required to ensure quality, efficacy, and timely completion of directed projects.

• Proactively works with team members to achieve established goals, budgets and timelines.

• Monitors department budgets closely and takes all necessary actions to ensure budget alignment.  Identifies capital needs for production and facilities to provide CapEx recommendations.

• Collaborates with department heads to develop and update engineering standard operating procedures.

• Ensures project compliance with all applicable laws and regulations, especially U.S. FDA regulations and EU Medical Device Regulation supporting Regulatory group.

• Researches and analyzes facility requirements and manufacturing capabilities / capacities around potential acquisition opportunities.

• Provides technical training for engineering and operations personnel. Provides systems training to other functional areas as necessary.

• Identifies Advanced Manufacturing Engineering needs and communicates these needs to Senior Management.

• Manages facilities maintenance activities through prioritization of safety, health and production needs.

• Identifies safety issues in the immediate work environment and other work areas and recommends solutions for improvement.

• Ensures engineering and facilities maintenance activities are in compliance with Quality System requirements.

• Ensures facility maintenance activities are also in compliance with OSHA and other applicable health and safety standards.

• Performs other related duties as required.

Authority and supervision: Directly manages Facility Maintenance and mentors junior engineers. Reviews and approves project team work and exercises sound business judgment, recognizing that errors may significantly affect the company.

+ Education and Experience

Education Requirements: Bachelor’s in Mechanical Engineering or applicable degree.

Experience Requirements:  8-10 years of Engineering (Manufacturing & Design) experience supporting products in post market phases of product lifecycle.  3- 5 years of leadership experience.  Five years in medical device industry desirable.

Job knowledge skills and abilities

• Proficiency in 2D drafting and 3D modeling, preferably AutoCAD and SolidWorks.

• Knowledge of ANSI Y14.5 drafting standards.

• Expertise in properties of various materials, such as stainless steel, aluminum and plastics.

• Expertise in part fabrication techniques, such as machining and injection molding.

• Expertise in the factors that affect the life of re-usable surgical instruments, such as corrosion, wear and thermal cycling.

• Thorough understanding of part tolerancing and tolerance stack-up analysis.

• Thorough understanding of mechanical stress analysis.

• Proficiency in Microsoft Office, Project and other job associated software.

• In depth understanding of regulatory requirements for medical device design control and manufacturing.

• In depth understanding of various surgical techniques as related to surgical instruments.

• Ability to apply scientific reasoning and to develop test methodologies to resolve complex technical problems.

+ Competencies

Advanced Manufacturing and Technical Leadership

Skills: Automation, insourcing, manufacturing processes, design for manufacturing, mechanical analysis, and root cause investigation.

Behaviors: Leads manufacturing initiatives from planning through implementation; guides technical decisions and resolves complex product and process issues using evidence.

Program Execution and Business Acumen

Skills: Project planning, risk and milestone management, budget control, CapEx evaluation, and cost savings analysis.

Behaviors: Sets priorities, coordinates resources, anticipates risks, and delivers projects within agreed budgets and timelines; connects investment decisions to business results.

People Leadership and Cross Functional Collaboration

Skills: Coaching, delegation, career development, technical training, communication, and stakeholder alignment.

Behaviors: Sets clear expectations, develops direct reports and junior engineers, holds teams accountable, and aligns Operations, Supply Chain,

Quality, and Engineering around shared goals.

Continuous Improvement and Lean Execution

Skills: Lean tools, kaizen and Blue Belt project coaching, CI planning, savings tracking, and process improvement.

Behaviors: Leads and coaches improvement initiatives, maintains a prioritized CI calendar, and verifies measurable gains in cost, quality, and delivery.

Quality Regulatory and Safety Stewardship

Skills: FDA and EU MDR requirements, design controls, Quality Systems, OSHA standards, and facilities maintenance prioritization.

Behaviors: Embeds compliance in engineering and maintenance work, identifies and addresses safety and quality risks early, and prioritizes maintenance based on safety, health, and production needs.

+ Work Environment, Physical Demands and Protective Equipment

Minimal physical demands, primary work in an office or lab environment.  May be required to do some travel, and to stand for periods of time during work or viewing surgeries.

Works primarily in an office or manufacturing environment, with periodic work in the engineering lab and prototype machine shop. Occasional travel may be required.

Follows protective equipment procedures for each department.  Adheres to medical facility precautions during cadaver labs and surgical procedures.  Hep B. vaccine series provided, documentation of vaccination or signed declination required.

Confidentiality: Access to the engineering CAD database, trade secrets, and information about new products requires maintaining confidentiality.

+ Schedule, Travel Responsibility, Special Conditions or Requirements

Occasional travel may be required, including visits to medical facilities, cadaver labs, or surgical procedures.

Training and certification requirements: See the individual training matrix in the Training Management System.

Pay Range: $125,000 - $155,000

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.