Engineer III

SGS_JOB_2264

Engineering
 Pennsylvania
Compliance with GMP
OSHA
EPA
FDA
ISO Standards
Management of Change (MOC) Process
Design Verification & Validation (DHF
GMP
FDA
ISO
CE)
Tooling & Automation Design (Semi/Automated Equipment)
Product & Process Development
Manufacturing Process Improvements (Melt Processing
Chemical
Machining
Mechanical)

Contract - 12 Months (possible extension)

Location (mandatory): Exton, PA 19341 (Onsite) Experienced in product and process development from prototype to full-scale manufacturing, with expertise in optimizing performance variables, scaling up processes, and implementing improvements in productivity, efficiency, and reliability. Skilled in designing novel tooling and automation solutions, supporting regulatory and quality compliance (GMP, FDA, ISO, CE), and leading cross-functional project teams across R&D, Operations, Quality, and Regulatory. Strong background in root cause analysis, continuous improvement, machine safety assessments, and design verification/validation, while also contributing to grant, patent, and regulatory filings. Proven ability to bridge research with commercialization by driving innovation, ensuring compliance, and supporting daily manufacturing operations.

Job Responsibilities:

  • Identifying and optimizing product/process variables required for maximizing product/process performance at prototype, lab/pilot, and full production scale
  • Leading evaluation of final product specifications by prototyping products/processes and performing experiments; from lab to production scale
  • Developing novel processes/tooling concepts for new process development, and evaluate concepts based upon manufacturing key performance indicators (KPIs)
  • Proving product/process performance at prototype, lab/pilot scale, and full production scale
  • Leading evaluation of scale up options, selection, & implementation by leading sub projects, providing project updates, and offering input for the next phases
  • Evaluate, identify and recommend/implement improvements (productivity, efficiency, reliability) to existing processes (melt processing, chemical, machining or mechanical) or products.
  • Support research efforts related to identifying and/or evaluating new technologies, biomaterials and/or medical implants.
  • Support Operations to address plant layout, resources, and start up milestones
  • Developing all necessary documentation to support new/or improved process scale up to manufacturing verification
  • Design, assemble and test semi-automated and automated tooling required to improve current processes, or needed for new projects/product lines
  • Create and/or process ECN’s, process routers, drawings, and other written documentation in accordance with GMP requirements to support product development, process development, validations and manufacturing.
  • Leading evaluation of potential new product/process proposals and provide recommendations as to the scope and necessary timing required for specific production targets
  • Developing project plans, estimating project costs, operating costs, project schedules milestones, and resource requirements.
  • Support customer quotations for new/changes to products/processes
  • Leading improvement of infrastructure and capabilities
  • Analyzing results of experiments against objectives/targets
  • Working with supervisors and other associates to ensure execution of experiments in a timely manner
  • Leading Machine design verifications reviews.
  • Support Design Verifications, Design & Development reviews, and Verifications & Validations for new product development.
  • Providing in-house development and/or technical support to Operations
  • Conducting investigations and implementation of improvements into manufacturing product/processing issues
  • Support Operations in the daily manufacturing of commercial products.
  • Conducting investigation into customer complaints and resolution as it relates to manufacturing process, equipment or product requirements
  • Providing in-house development and/or technical leadership to Operations
  • Leading continuous improvement on projects/processes to achieve improvements in productivity, yield and/or operating costs
  • Leading investigation and performing root cause analysis into customer complaints
  • Support preparation of applicable technical sections for grants, patent, & regulatory filings
  • Leading Management of Change (MOC) review process
  • Participating in HAZOP and PSA teams as needed
  • Leading Machinery Safety Assessment (MSA)
  • Following DSM Life Saving Rules (LSR), encourage fellow colleagues to work to the same standards.
  • Following Design Control and Risk Management procedures
  • Participate in auditing medical device design history files
  • Assist in the preparation of applicable technical sections of regulatory documents (FDA 510k, IDE, PMA, CE), grants, & patent filings.
  • Keep up to date on industrial and academic technological developments and exploring opportunities to incorporate them into process development/commercialization process
  • Directing or participating in project teams within the PMP/Project Management process
  • Execute the job within the applicable DSM, GMP, OSHA, EPA, ISO, FDA, CE, & other requirements.
  • Directing or participating in a variety of projects with cross-functional project teams. Collaborating with Strategic Business Innovation, Strategic Business Management, Research & Development, Quality, Regulatory, Safety, Finance, & Manufacturing groups.
  • Participating in Engineering Change Notice (ECN) Board

Skills:

  • 7+ years of hands-on experience in a fast-paced manufacturing environment, preferably in medical equipment or devices.
  • Demonstrated experience designing, building, and maintaining small tools and fixtures using Creo or related software packages.
  • Experience generating ideas, getting business support, and then driving the idea to an implemented solution.

Education/Experience:

  • Bachelor of Science degree in Mechanical, Chemical, or Industrial Engineering.
  • Other engineering-related degrees will be considered with relevant experience.

Related Jobs

Audio Software Engineer

Engineering
 Washington
6 Months

Location: Redmond, WA We are seeking a highly skilled and motivated Software Engineer to join our specialized engineering team. This role is centered on the development of sophisticated software for advanced hardware control and lab automation, with a primary focus on aero-acoustic wind tunnel systems. In this role, you will use Python to design, build, and enhance control mechanisms for both a classic recirculating wind tunnel and a novel modular fan-array wind tunnel. This position offers a unique and exciting opportunity to work at the intersection of software development, robotics, acoustics, and aerodynamics.

Python
Audio
Robotics
Data Acquisition
Signal Processing

Software Engineer II

Engineering
 Washington
04 Months

This role sits at the center of our team's expansion and will have a direct impact on documentation, processes, and customer relationships. Work will vary from tool evaluation and integration to day-to-day hands-on lab and infrastructure support. In addition to core engineering responsibilities, this role requires a strong grasp of AI technologies and hands-on proficiency with AI-assisted development tools such as Claude Code. As AI reshapes how engineering work gets done, this engineer will be expected to leverage AI tooling in their own workflows and help drive adoption across the team. This role will operate as a point of contact for assigned projects, coordinate internal resources, and be supported by supervisors and technical resources. This person must be willing to take direction from leadership while also providing guidance and driving task ownership across team members. Our goal is to build and maintain strong, long-lasting customer relationships.

AI Assisted Development Tool – Claude Code
Python
LinuxOS
System Administration

Systems Engineer III

Engineering
Remote
12 Months

The main function of a systems engineer is to apply the principles of computer science and mathematical analysis to the design, development, testing, and evaluation of the software and systems that make computers work. A typical systems engineer analyzes user needs, and then designs, tests, and develops software to meet those needs.

Systems Engineering
Server Lifecycle
Troubleshooting
Test
TCP/IP Network
Linux
Server Management.

Data Engineer IV – Marketing & Ads

Engineering
Remote
08 Months

Location - Remote

SQL
Python
ETL
Marketing
Ads
Large Data Sets

Linguist III - German and Turkish Both

Engineering
Remote
09 Months

Location - Remote

Linguistics
Phonetics
Phonology
Regex
SQL
Python
Native Speaker of German or Turkish

Network Engineer II

Engineering
 California
$67 - $75/Hr. on W2
06 Months

Contract - 06 Months Pay Rate : $67 - $75/Hr. on W2 The Network/System Lab Engineer will support the our team by bringing up and maintaining the network lab environment. Responsibilities include integrating and troubleshooting new network equipment, coordinating delivery and installation of new products, testing switch testbeds for software validation, and maintaining accurate lab inventory records. The ideal candidate will have hands-on experience with network devices, strong problem-solving skills, and the ability to work in a fast-paced lab setting. Must be detail-oriented, organized, and able to communicate effectively with cross-functional team

IP
Cisco IOS
JunOS
Python
Power Supply
Network Device Bring-Up
Lab Work

Application Engineer – Rockwell

Engineering
 South Carolina
6 Months

Location (mandatory): Saint George, SC Seeking a skilled engineer to deliver high-quality designs and testing in accordance with project specifications, standards, budgets, and timelines. This role involves providing centralized software support for critical BMS applications. The successful candidate will collaborate with a team to design, install, commission, and service building automation and facility management systems.

SCADA
PLC
Rockwell
BMS

Analyzing Technician

Engineering
 Illinois
3 Months

Location (mandatory): Elgin, IL We are seeking a highly skilled Analysis Technician to join our dedicated team for the 1st shift. Based at our state-of-the-art facility, you'll be responsible for board-level analysis of failed 2-way subscriber products (both mobile and portable 2-way radios). This is an exciting opportunity to leverage your technical expertise in testing, diagnosing, and repairing electronic assemblies to identify the root causes of failures.

Electrical Engineer
RF

IT Manager

Engineering
British Columbia
4 Months

Location (mandatory): Vancouver, BC Maintain the lab infrastructure, network infrastructure, and asset/equipment inventory. Maintain and troubleshoot hardware, including: Cameras Workstations Servers Switches

System Administration
Camera Installation and Troubleshooting
logo

At SGS Consulting, we go beyond resume-job matches, creating meaningful connections and pathways for individuals to thrive in defining careers.


© 2026 All rights reserved.
logologologologo