Lead Advanced Manufacturing Engineer

DIRECT SALES, US; Louisville (CO); On-site; USD 119,000 - 187,000; Full time

Benefits offered by this job

Annual bonus

Training & development

Job summary

Hologic in Colorado is seeking a Lead Advanced Manufacturing Engineer to drive design for manufacturability, transfer of manufacturing processes and qualification for new products. You will lead large, complex projects across subsystems and liaise between Product Development and Manufacturing teams.

The role requires deep hands-on experience with DFM/DFA/DFI reviews, design transfer, IQ/OQ/PQ, MSA, Cp/Cpk and GD&T, plus strong technical writing and mentoring abilities.

Qualifications

• Strong technical writing ability for process development reports, validation protocols and reports.
• Experience with design transfer and process validation (IQ/OQ/PQ) and MSA.
• Knowledge of manufacturing processes for handheld surgical instruments and disposables.
• Experience with tooling/fixture design for molds and assembly fixtures.
• Familiarity with risk management tools like FMEA and control plans.

Responsibilities

• Lead advanced manufacturing engineering for large, complex projects, including strategy, architecture, and design transfer.
• Coordinate between Product Development and Manufacturing teams.
• Drive manufacturability, capability, and cost requirements into product design.
• Develop and qualify manufacturing processes, tooling, and fixtures from feasibility to production.
• Lead technical project meetings and present to support decisions.
• Interact with project teams, suppliers, customers, and others; work with Sourcing and Supplier Quality.
• Prepare and review scopes, budgets, and schedules.
• Lead pilot builds, design transfer, IQ/OQ/PQ, and MSA.
• Apply risk management tools to identify and mitigate process risks.
• Mentor and develop other engineers.
• Communicate effectively to drive best business decisions.

Skills

Technical learning

Communication

Problem solving

DFSS

DOE

GD&T

SolidWorks

Lean Six Sigma

Education

Bachelor's in Mechanical/Manufacturing/Biomedical Engineering

Tools

SolidWorks

Job description

Job Summary

• Lead Advanced Manufacturing Engineer possessing excellent technical judgment and a deep understanding of design for manufacturability to lead the development, qualification, and transfer of manufacturing processes for new products.

Essential Duties and Responsibilities

The candidate may be asked to perform other function-related activities in addition to the below mentioned as responsibilities as reasonably required by business needs.

This position is responsible for performing the following tasks as assigned while receiving strategic supervision and some guidance with assignments given in terms of broad general objectives and limits:

• Technically leads advanced manufacturing engineering for large, complex projects, including the manufacturing strategy, process architecture, and design transfer plan across multiple subsystems, while managing short & long term deliverables to meet project milestones.
• Liaison between the Product Development and Manufacturing teams
• Leads design for manufacturability, assembly, and inspection (DFM/DFA/DFI) reviews with R&D, and drives manufacturability, capability, and cost requirements into the product design.
• Develops and qualifies manufacturing processes, tooling, and fixtures for new products, from feasibility through pilot builds to production release.
• Leading technical project meetings and making presentations to support technical decisions.
• Routinely interacts with project teams, suppliers, customers, contractors, and others. Works closely with Sourcing and Supplier Quality on supplier selection
• Prepares and reviews scopes, budgets, and schedules for assignments and projects.
• Leads and/or directs pilot builds, design transfer, process validation (IQ/OQ/PQ), process capability studies, and measurement system analysis (MSA).
• Applies broad knowledge of risk management tools, including process FMEA and control plans, to identify, assess, and mitigate process risks throughout the entire product lifecycle.
• Formulates and solves problems that require significant depth of technical knowledge and/or skillset.
• Applies broad knowledge of principles and practices in multiple practice areas to solve complex problems.
• Prepares complete project documents, including process development reports, validation protocols and reports, and manufacturing procedures. Reviews complete project documents for conformity and quality assurance.
• Researches new techniques, manufacturing technologies, and theories in related fields to help support completion of assignments.
• Collaborating cross-functionally to develop methods and processes that facilitate decisions and improve results.
• Assists upper-level management and staff as a technical specialist or advisor on manufacturability, process capability, and manufacturing cost.
• Effectively communicates to cross-functional teams to drive the best decisions for the business.
• Active role in mentoring and developing other engineers.
• Reviews operational procedures to ensure compliance with applicable policies and performance measures.

Supervisory Responsibilities

• N/A

Qualifications

Education

• Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related field with manufacturing or process development experience in the medical device industry

Experience

• 8 years of work experience in the health and/or business communities with Bachelor’s Degree
• 6 years of work experience in the health and/or business communities with Master’s Degree

Skills

• Action and detail oriented with an aptitude for technical learning
• Fast and accurate communication to team members and management
• Strong functional and technical skills, problem solving skills and a drive for results
• Apply knowledge and expertise acquired through progressive experience to develop teams, resolve crucial issues, and/or unique conditions.
• Evaluate, select, and apply standard techniques, procedures, and criteria to perform a task or sequence of tasks for projects with highly complex features.
• Strong technical writing ability, able to independently author process development reports, validation protocols and reports, work instructions, and risk documentation. Relied upon for thorough review of documentation, including department procedures.
• Deep knowledge of manufacturing processes used for handheld surgical instruments and disposables (e.g., injection molding, machining, metal forming, extrusion, common joining methods including welding and adhesive bonding, and rapid prototyping)
• Deep knowledge of tooling and fixture design, including mold and assembly fixture specification
• Proficient with design transfer and process validation: IQ/OQ/PQ, process capability (Cp/Cpk), measurement system analysis, and sampling plan rationale
• Proficient with process risk and control tools
• Strong experimental, computational, and analytical skills such as DFSS tools, statistical methods including design of experiments (DOE) and MiniTab
• Proficient with tolerance stack ups, DFM, and GD&T
• Expert using CAD – SolidWorks preferred
• Working knowledge of Lean Six Sigma methods
• Keep informed of new methods and developments affecting the organization and recommend new practices or changes.

Physical Demands

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• The employee is regularly required to sit, stand, walk, and reach with hands and arms, use hands to finger, handle, feel, and be able to talk and hear.
• Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus.
• Ability to lift or move up to 25 pounds.
• Ability to work flexible hours.

Travel

• Ability to travel as necessary up to 20%.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

The annualized base salary range for this role is$119,300 - $186,600and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.