Manufacturing Electrical Engineer

Manufacturing Electrical Engineer

Location: Plano, TX (fully onsite) Job ID: Sedaa - 48917 Note: Local candidates and candidates willing to relocate. No C2C candidates.

Position Summary

The Manufacturing Electrical Engineer II will support manufacturing operations through the development, maintenance, troubleshooting, and continuous improvement of electrical test systems, automated equipment, and manufacturing processes. This individual will collaborate closely with production, quality, and cross-functional engineering teams to ensure product quality, equipment reliability, operational efficiency, and compliance with applicable quality system requirements. The ideal candidate will have a strong electrical engineering background and experience supporting manufacturing environments.

Candidate Profile

Seeking a hands-on Manufacturing Electrical Engineer who can quickly contribute to manufacturing operations by supporting electrical test systems, troubleshooting equipment issues, and driving continuous improvements that enhance product quality and manufacturing efficiency.

Key Responsibilities

• Support day-to-day manufacturing operations by troubleshooting electrical and automated production equipment.
• Develop, maintain, and optimize electrical test systems and manufacturing processes.
• Drive continuous improvement initiatives to enhance equipment performance, reliability, and productivity.
• Collaborate with Production, Quality, Manufacturing, and Engineering teams to resolve technical issues and implement corrective actions.
• Analyze equipment and process performance data to identify opportunities for improvement.
• Assist in root cause investigations and implement sustainable solutions.
• Ensure manufacturing equipment and processes comply with quality system and regulatory requirements.
• Support equipment qualifications, validations, and process improvement projects.

Required Experience

• Bachelor's degree in Electrical Engineering or a related engineering discipline.
• 3–5 years of experience supporting manufacturing operations in a regulated or high-volume production environment.
• Experience with Automated Test Equipment (ATE), data acquisition systems, or manufacturing testers.
• Proficiency using oscilloscopes, multimeters, and other diagnostic tools.
• Familiarity with electrical schematics and circuit troubleshooting.
• Strong problem-solving and root cause analysis skills.
• Ability to work effectively in a cross-functional team environment.

Key Skills

• Electrical Engineering
• Manufacturing Support
• Electrical Test Systems
• Automated Equipment Troubleshooting
• Continuous Improvement
• Root Cause Analysis
• Process Optimization
• Equipment Reliability
• Quality Systems Compliance
• Cross-Functional Collaboration

Preferred Experience

• Medical device, pharmaceutical, biotech, or other regulated manufacturing industry experience.
• Experience with equipment validation, qualification, or process validation activities.
• Knowledge of Lean Manufacturing and Continuous Improvement methodologies.
• Experience with PLCs, automation controls, and manufacturing data analysis.

Education

Bachelor's Degree in Electrical Engineering or related engineering field required.

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Manufacturing Automation Engineer

Location: Westbrook, ME (fully onsite) Pay Rate: $75,000–$85,000 per annum Job ID: Sedaa - 45717 Note: Local candidates only. No C2C candidates.

Position Summary

The position of Senior Manufacturing Automation Engineer is within our Infectious Disease Developed Markets Business Unit located in Scarborough, Maine. This role will be responsible for supporting manufacturing processes, quality/cost savings initiatives and implementation of engineering principles while assuring compliance with cGMP quality and safety standards.

This job description will be reviewed periodically and is subject to change by management.

Responsibilities

• Carry out duties in compliance with established business policies and procedures.
• Demonstrate commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• Exhibit professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
• Support department by performing related tasks as requested.
• Specify, acquire, and implement equipment.
• Lead automation equipment upgrade efforts related to safety, obsolescence, and continuous improvement initiatives.
• Evaluate machine logic, electromechanical and process controls to troubleshoot equipment and drive to resolution.
• Lead teams to identify root cause of manufacturing failures using structured problem solving and apply root cause fixes to prevent recurrence.
• Conduct failure modes and effects analysis and evaluate manufacturing equipment risk.
• Complete complex projects based on comprehensive knowledge of manufacturing equipment and processes.
• Lead design of experiments, validation, completion of testing and analysis of data. Present data to cross functional teams.
• Drive implementation of new methods or materials for continual improvement of quality and efficiency.
• Analyze current equipment for process suitability and provide detailed plans for improvement.
• Create and revise manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and other technical documents to ensure compliant, efficient, and safe procedures.
• Lead other engineers and technicians in developing solutions and improvements in materials, equipment, and process as necessary in addition to ensuring continual improvement, safety, and compliance.
• Manage cross functional project teams and coordinate activities.
• Provide training and process expertise for product processing in specific areas such as process development, tooling development, documentation, cleaning protocol, process characterization and validation.
• Initiate and lead to resolution of Quality Incidents and CAPA.
• Participate in teams as necessary and mentor junior engineers and maintenance technicians to ensure continual improvement, safety, and compliance.
• Consider safety, ergonomic, maintenance, and operator impact on manufacturing design.
• Interact with the local Project Management Office on milestones and project status updates.
• Participate in site strategy meetings and planning.
• Lead change through Agile PDM.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Basic Qualifications

Education

• Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
• 7+ years engineering experience in a manufacturing environment.
• Experience in the application of lean six sigma principles and the DMAIC approach or a similar structured problem-solving system.
• Proficiency in change management principles and processes.

Preferred Qualifications

• Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations.
• Experience working in a GMP, FDA, ISO and USDA regulated environment.
• Experience in cGMP and ISO 13485 regulations and practices.
• Experience in statistical analysis software.
• Experience in Microsoft Suites software (Microsoft Excel, PowerPoint, Power BI, etc.).

Competencies

General Competencies

• Innovative Thinking: Independently generates new, creative, and sometimes unconventional ideas to problem solve or improve current processes and structures while seeking feedback from managers and coworkers.
• Multitasking: Demonstrates the ability to handle multiple tasks or responsibilities simultaneously by efficiently managing time, prioritizing tasks, and maintaining productivity across different activities.
• Self-Motivated: Demonstrates a proactive attitude, consistently drives personal and team goals, and maintains high productivity with minimal external supervision.
• Verbal and Written Communication: Effectively conveys ideas in both individual and group settings, adapting style and methods to suit the audience's needs, both verbally and in writing.
• Teamwork and Collaboration: Demonstrates professional cooperation by working together harmoniously with others, being an integral part of a team, respecting others' contributions, and aligning personal goals with those of the team.

Technical Competencies

• Fabrication Principles: Proficiency in fabrication principles including CNC, lathe, milling, welding, and bolted connections.
• Mathematical Aptitude: Proficiency in mathematical concepts such as ANSI/AQL, probability, and statistics.
• Technical Aptitude: Proficiency in the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• CAD: Experience in computer-aided design (CAD) and manufacturing software for designing system layouts.
• Materials Testing: Proficient in a variety of testing and measuring methods relating to the process of evaluating the properties and performance of materials used in manufacturing.

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Manufacturing Engineer

Location: Minnetonka, MN (on-site role) Pay Rate: $40,000–$55,000 per annum Job ID: Sedaa 44324 Status: Non-Exempt. Hours over 40 will be paid at Time and a Half. Note: Local candidates only or open to relocate to Minnetonka, MN. No C2C candidates.

Duties and Responsibilities

• Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company's environment to take an effective and proactive leadership role in a specific technical manufacturing discipline.
• Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks that may have multiple inter-coordinating elements.
• Anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required.
• Apply new methods and approaches and consider the impact with other system components.
• Interact with peers and mentors on individual projects in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.

Qualifications

• Bachelor Science or Bachelor Engineering in Electrical, Software, or Mechanical Engineering.
• Typically a minimum of 2–5 years experience in an engineering discipline or advanced education to achieve the level of skill.

Experience and Skills

• Medical device experience and ISO/GMP training an advantage.
• Knowledge of Microsoft based computer software programs.
• Must be a team player.
• Good attention to detail.
• Must be able to lift 50 lbs.
• Must be able to sit/stand for 2 to 3 hours at a time.

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Manufacturing Engineer

Location: Saint Paul, MN (100% on-site role) Pay Rate: $40,000–$58,000 per annum Job ID: Sedaa 44365 Note: Local candidates only or open to relocate to Minnetonka, MN. No C2C candidates.

Position Summary

This position works out of our Minnetonka MN location in Electrophysiology (EP) business. Individuals in this role will work on a new product launch supporting the operations team as a 1st shift Manufacturing Engineer working with assemblers and leading technicians on troubleshooting equipment and investigating process issues. Additionally, this position will support projects aimed towards designing and developing manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality. This individual will have a unique opportunity to make a mark on the organization, while working on state-of-the-art product.

What You'll Work On

• Front line Manufacturing Engineer supporting Operations team in a clean room environment.
• Support products which include new production equipment, process improvements and cost reductions while supporting new product introductions.
• Lean manufacturing processes, techniques and best practices and support Operations team in coaching assemblers through daily activities and training certifications.
• Instruct production personnel in the manufacturing and testing of product devices.
• Recommend and implement process, tooling, equipment changes for improving safety, quality, delivery and cost.
• Interpret test data, analyze product performance, develop summaries, and assist in the initiation of yield improvements.
• Daily troubleshooting of safety, quality or process issues.
• Perform scrap dissection and lead investigation into potential root causes.
• Summarize information to communicate across shifts and with other functional areas, and reporting to leadership team.

What You Should Bring

Individual should:

• Be innovative, resourceful, and work with minimal direction.
• Have excellent organization, problem solving, communication, and collaboration skills.
• Work effectively with cross-functional teams.
• Exercise technical knowledge to support achievement of business objectives through launch of the product, volume ramp and yield improvement, which will require setting direction, leading, and taking ownership of complex manufacturing engineering technical tasks with multiple inter-coordinating elements.
• Anticipate and identify key issues, understand impact and make recommendations for resolution which remain compliant with Quality System requirements.
• Obtain peer review and manager review to confirm rationale for the approach is appropriate.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Shift

1st Shift: Mon - Thurs, Approximately 5:00 AM – 3:30 PM

Precise times may be shifted to accommodate other shift schedules, early shift support or other project work. This position will begin as a 1st shift role but may later switch to second shift (3:30 PM - 2:00 AM). Ideal candidate will be able to flex across both shifts for training, cross-shift coverage when needed or alignment for future line support needs. Candidates who cannot flex will still be considered, however the ability to flex is a strong plus. Additionally, while shifts are 10 hrs, Mon-Thurs, there is a strong opportunity for Overtime on Fridays & Saturdays and ability to support is desired.

Required Qualifications

• The individual will typically have had 2–5 years experience in an engineering discipline or advanced education to achieve the level of skill.
• Bachelor Science or Bachelor Engineering in Electrical, Mechanical or Biomedical Engineering or similar is desired.
• Curriculum training will be provided to ensure understanding of Quality System requirements required to perform assignments.
• This position is Non-Exempt. Hours over 40 will be paid at Time and a Half.

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Manufacturing Engineer

Location: Saint Paul, MN (100% on-site role) Pay Rate: $40,000–$62,000 per annum Job ID: Sedaa 44210 Note: Local candidates only or open to relocate to Saint Paul, MN. No C2C candidates.

Position Summary

Selected Candidate will start ASAP after screenings have cleared.

Top Skills

• Excellent documentation skills
• High attention to detail
• General mechanical engineering knowledge with the ability to quickly step into the initiative after training
• Excellent documentation and execution skills

Education

Bachelor Science or Bachelor Engineering in Electrical, Software, or Mechanical Engineering.

Experience

3–5 years prior experience preferred.

What You'll Do

• Review documentation of procedures and ensure proper execution of protocols and SOPs as part of the site's integration into Client.
• Support the maintenance of controlled process documentation, including work instructions, process flow diagrams, gap analysis, control plans, and risk-management documentation.
• Exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company's environment to take an effective and proactive leadership role in a specific technical manufacturing discipline.
• Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks that may have multiple inter-coordinating elements.
• Anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required.
• Apply new methods and approaches and consider the impact with other system components.
• Interact with peers and mentors on individual projects in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.

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Manufacturing Engineer

Location: Austin, TX (100% on-site role) Pay Rate: $40,000–$68,000 per annum Job ID: Sedaa43310 Note: Local candidates only or open to relocate to Plymouth, MN. No C2C candidates.

Key Responsibilities

• High Priority: Plan, implement, and manage engineering projects for automated assembly lines, including development, build, testing, commissioning, and validation.
• High Priority: Manage complex automation engineering projects and new product development across multiple global sites.
• Drive activities with equipment suppliers to ensure successful production start-up and scale-up.
• Lead design, planning, and sustaining of automated manufacturing systems.
• Ensure adherence to quality, regulatory, and corporate standards; report progress against timelines.
• Identify and escalate risks impacting project delivery, product quality, or safety.
• Interface with cross-functional teams including R&D, Quality, Regulatory, and Operations.
• Develop and implement innovative solutions and manage engineering changes.
• Conduct complex engineering studies, analyze data, and prepare technical reports.
• Create process documentation and technical procedures for medical device equipment.
• Perform root cause analysis and implement corrective actions for yield and cycle time issues.
• Travel up to 10% (primarily Europe and U.S.) for project-related activities.

High Priority Qualifications

• Prior experience in medical device or pharmaceutical environments (FDA/cGMP/ISO regulated).
• Strong knowledge of automation systems, validation lifecycles, and high-volume manufacturing lines.
• Excellent project management, communication, and problem-solving skills.

Qualifications

• Bachelor's degree in Engineering/Manufacturing or related discipline (Automation/Electronics/Mechatronics preferred).
• Minimum 5+ years of progressive technical experience; experience with automated manufacturing processes preferred.
• Ability to work independently and in a fast-paced, team-oriented environment.
• Familiarity with equipment software, pneumatics, electronics, vision systems, lasers, and GAMP guidelines.

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Manufacturing Engineer - I

Location: Pomona, California (100% on-site role) Pay Rate: $30,000 per annum Note: Local candidates only or open to relocate to Plymouth, MN. No C2C candidates.