Electrical Engineer 3

Hologic, Inc.; Newark (DE); On-site; USD 99,000 - 154,000; Full time

Job summary

Hologic, Inc. seeks a qualified engineer to design, develop, and optimize components and processes for medical device manufacture. You will analyze equipment, establish manufacturing procedures, and collaborate with R&D and Facilities to improve efficiency and quality.

The role requires strong problem-solving, cross-functional collaboration, and experience with Lean, Six Sigma, and regulatory environments. Expect involvement in complex experiments and process improvements across multiple

Qualifications

• 5 to 8 years of relevant experience with a non-technical degree.
• 2 to 5 years of experience with a Bachelor's degree, 1 to 3 years with a Master's degree, or 0 to 1 years with a PhD.
• Experience with schematic capture and PCB layout software.
• Automation experience, including implementation of automated manufacturing cells or production lines.
• Experience in FDA-regulated medical device environment is highly desirable.
• Experience supporting rapid scale-up of new products or manufacturing operations is beneficial.

Responsibilities

• Performs complex experiments that may require coordination of other engineers or technicians.
• Actively participates in R&D projects by providing design input and ensuring projects can be translated into cost-effective production processes.
• Responsible for the manufacturing performance of assigned product line(s).
• Establishes fabrication and assembly procedures to support product manufacturing and develops tooling requirements.
• Initiates and/or approves changes in design, drafting, tooling, methods, processes, and documentation affecting manufacturing operations.
• Oversees the creation and revision of SOPs and directives related to scheduling, cost control, and production performance evaluation; develops, verifies, and validates manufacturing processes.
• Supports maintenance of production equipment and collaborates on predictive maintenance programs.
• Identifies, diagnoses, prioritizes, and resolves technical issues during manufacturing operations; partners with cross-functional teams.
• Evaluates and develops process control data for trending and analysis; investigates defects and implements improvements.
• Participates in design reviews and collaborates with R&D and Manufacturing to resolve issues.
• Actively supports and adheres to the company's Quality Policy and Quality System procedures.
• Conducts process analyses and leads Kaizen Events and Process Improvement initiatives to improve efficiency and quality.
• Manages multiple projects independently.

Skills

Lean Six Sigma Green Belt

Root Cause Analysis

Process Improvement

Technical drawing

Cross-functional collaboration

PCB design/layout understanding

FDA compliance

Schematic capture

Education

Bachelor's degree in Engineering or related field

Advanced degree (Master's or PhD) preferred

Tools

Schematic capture software

PCB layout software

Automation equipment

MS Office

Job description

Job Summary

Designs, develops, modifies, and evaluates components and processes used in the generation, manipulation, transmission, and storage of electricity. Determines design approaches and parameters. Analyzes equipment to establish operating data, conducts experimental testing, and evaluates results. Selects components and equipment based on specifications, performance, and reliability requirements. Completes documentation and procedures for installation and maintenance activities. May interact with users to define system requirements and identify necessary modifications.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates sound judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel within their area of expertise.

Possesses a full understanding of the area of specialization and resolves a wide range of issues in creative and practical ways. This is a fully qualified, career-oriented professional position that typically receives little instruction on day-to-day work and general guidance on new assignments.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to those listed below, as reasonably required by business needs.

• Performs complex experiments that may require support and coordination of other engineers or technicians.
• Actively participates in R&D projects by providing design input and ensuring projects can be translated into cost-effective production processes. Supports R&D in developing cost estimates for equipment, tools, and components.
• Responsible for the manufacturing performance of assigned product line(s).
• Establishes fabrication and assembly procedures to support product manufacturing. Develops methods and tooling requirements for new and existing processes and assists in the design of tooling and fixtures.
• Initiates and/or approves changes in design, drafting, tooling, methods, processes, and documentation that impact manufacturing operations.
• Oversees the creation and revision of standard operating procedures (SOPs), organizational standards, and directives related to scheduling, cost control, and production performance evaluation. Develops, verifies, and validates manufacturing processes.
• Supports the maintenance of production equipment and collaborates with Facilities on the implementation of predictive maintenance programs.
• Identifies, diagnoses, prioritizes, and resolves technical issues that arise during manufacturing operations. Partners with cross-functional teams as needed.
• Evaluates and develops process control data for trending and analysis. Investigates defects, provides feedback, and implements process improvements.
• Participates in design reviews and collaborates with R&D and Manufacturing teams to resolve issues, particularly those involving design standard violations or changes to existing manufacturing procedures.
• Actively supports and adheres to the company's Quality Policy and Quality System procedures.
• Conducts process analyses and leads activities including Defect Reviews, Kaizen Events, and Process Improvement initiatives to improve manufacturing efficiency, product quality, and operational effectiveness.
• Manages multiple projects independently.

Qualifications

Education

• Bachelor's degree in Engineering or a related technical discipline preferred.
• Advanced technical degree (Master's or PhD) preferred.

Experience

• Typically requires 5 to 8 years of relevant experience with a non-technical degree.
• Typically requires 2 to 5 years of experience with a Bachelor's degree, 1 to 3 years with a Master's degree, or 0 to 1 years with a PhD.
• Experience with schematic capture and PCB layout software.
• Automation experience, including implementation of automated manufacturing cells or production lines.
• Experience in an FDA-regulated medical device environment is highly desirable.
• Experience supporting rapid scale-up of new products or manufacturing operations is beneficial.

Skills and Competencies

• Advanced proficiency with Microsoft Office applications.
• Strong written, verbal, and interpersonal communication skills.
• Excellent organizational and time management skills.
• Ability to read, interpret, and create technical drawings.
• Working knowledge of manufacturing, quality improvement, and cost reduction methodologies, including Lean Manufacturing, Root Cause Analysis, Root Cause Failure Analysis, TQM, SPC, and Six Sigma.
• Ability to develop and lead corrective action plans.
• Proven ability to work effectively as both an independent contributor and collaborative team member.
• Self-motivated with a strong sense of initiative.
• Understanding of electronic design, medical device design, analog and digital circuit design, PCB design, software systems, optics, and human factors engineering.
• Knowledge of IEC 60601-1 and IEC 60601-2 standards.
• Leadership and team development experience is a plus.
• Prior people management experience is beneficial.
• Lean Six Sigma Green Belt certification is preferred.

Compensation

The annualized base salary range for this role is $98,500 to $154,000 and the position is eligible for an annual bonus. Final compensation will be determined based on factors including experience, skills, education, location, business needs, and market conditions.

Equal Opportunity Employer

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

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This position must comply with all applicable FDA regulations and ISO requirements.

Hologic is an equal opportunity employer inclusive of female, minority, disabled, and veteran individuals (F/M/D/V).