Staff Manufacturing Engineer

POSITION SUMMARY:

The Staff Manufacturing Engineer serves as a technical leader within Manufacturing Engineering, responsible for developing manufacturing strategies, scalable assembly processes, and equipment architectures that support new product development from concept through commercialization. This role leads the development, validation, and implementation of custom manufacturing equipment and processes in a concurrent engineering environment while advancing Design for Manufacturability, Design for Assembly, Lean, Six Sigma, validation, and continuous improvement practices. The Staff Manufacturing Engineer provides technical leadership across cross-functional teams, mentors engineers, partners with suppliers, and influences manufacturing decisions that support quality, cost, scalability, and long-term operational performance.

ESSENTIAL FUNCTIONS OF THE POSITION:

Ensures continuous improvement in process, cost, quality and production

Responsible for coaching/mentoring members of the Manufacturing/Process Engineering Teams

Supports and drives a DFM focused culture within the PD teams and the operations organization

Supports and drives a continuous improvement culture within the PD teams and the operations organization

Represents manufacturing on cross functional projects, both internal and external.

Defines high level manufacturing system/flow requirements and selects appropriate manufacturing processes to achieve required tolerances, production capacities, and cost targets.

Collaboration with product design engineers to identify and implement Design for Manufacture/Design for Assembly improvements.

Has knowledge of tolerance capabilities of processes such as machining, molding, casting, stamping, forming, grinding, etc. Understands GD&T and how to properly apply it to yield the desired fits between joining parts

Applies lean manufacturing (Toyota production system) principles to the design of manufacturing processes, facilities layouts and business processes associated with manufacturing.

Participates in development of product requirements and leads manufacturing risk management activities (Process FMEA, Validation Master Plan, Inspection and Test methods)

Selection of suppliers for parts and equipment.

Coordination of prototype and pre-production builds.

Specifies, designs and manages procurement of equipment, fixtures and tooling.

Applies project management best practices to manufacturing engineering projects including development of work breakdown structures, identification of required resources, budgeting and management of required expenses, and daily task and resource management to achieve expected project outcomes.

Leads development of custom automated and semi-automated assembly equipment from concept through production release including specification development, design reviews, FAT, SAT, installation and validation.

Drives Design for Manufacturability (DFM) and Design for Assembly (DFA) throughout product development to improve manufacturability, automation readiness, quality and cost.

Participates as a core manufacturing engineering leader in concurrent engineering teams from concept through commercialization.

Applies Lean Manufacturing and Six Sigma methodologies including DOE, MSA, SPC, process capability (Cp/Cpk) and statistical analysis.

Leads Process FMEA, Control Plans, Validation Master Plans, IQ/OQ/PQ protocols and manufacturing risk mitigation activities.

Uses advanced GD&T knowledge, tolerance analysis and manufacturing capability to influence product design.

Leads equipment suppliers through concept, design, build, debug and production launch.

Balances technical performance, quality, cost, schedule and manufacturing scalability when making engineering recommendations and strategic manufacturing decisions.

Develops business cases and capital expenditure (CapEx) justifications for manufacturing equipment, automation and process improvement investments, including ROI, throughput, labor savings and technical risk assessments.

Leads technical and financial make-versus-buy evaluations for manufacturing equipment, tooling, fixtures, processes and component manufacturing by assessing cost, quality, technical capability, capacity, timeline, risk, scalability and long-term business strategy. Provides recommendations to leadership supported by data-driven analysis.

Develops project schedules, budgets, resource plans and risk mitigation strategies while communicating status to leadership.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

Regular and predictable work performance

Ability to work under fast-paced conditions

Ability to make decisions and use good judgment

Ability to prioritize various duties and multitask as required

Ability to successfully work with others

Additional duties as assigned

BASIC QUALIFICATIONS:

Bachelor’s degree in Industrial Eng., Biomedical Engineering or Mechanical Eng. or equivalent is required

10+ years of related experience developing new manufacturing processes and the tooling, fixtures, and equipment required for implementation.

Knowledge base in Lean Processes and Continuous Improvement

Experience in Design for Manufacturability

Experience with medical device design and manufacture

Previous class II or class III Medical Device manufacturing experience

Possess a strong knowledge of manufacturing processes and capabilities. Able to provide guidance in process and supplier selection when necessary.

Self-motivated with strong time management skills

Ability to translate broad strategies into specific objectives and action plans

Experience with technical report writing and strong written and verbal communication skills.

Must be able to read blueprints and interpret technical specifications and illustrations

Comfortable driving multiple initiatives at a rapid pace

Creative thinker with exceptional process, analytical, management and relationship skills

Problem solving/trouble shooting experience

PREFERRED QUALIFICATIONS:

Six Sigma Green Belt or Black Belt

PMP certification or demonstrated project leadership

Experience developing automated medical device assembly equipment

Experience with FDA Design Controls, Design Transfer and ISO 13485

Experience with robotics, vision systems and automated inspection

OTHER REQUIREMENTS:

Ability to regularly walk, sit and stand as needed

Ability to occasionally bend, reach, push and pull as needed

Ability to infrequently lift up to 50 pounds

Ability to work in and around a manufacturing environment and machinery

Ability to travel as needed

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