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

Data Analyst III

Engineering
Remote
12 Months

Summary: The main function of a data analyst is to coordinate changes to computer databases, test, and implement the database applying knowledge of database management systems. A typical database analyst/programmer is responsible for planning, coordinating and implementing security measures to safeguard the computer database. Good to have skills: Can self manage projects- set expectations

SQL
Python
ETL
Marketing Campaign
Tableau

Visual Designer IV

Engineering
Remote
06 Months

Summary: The Cross- Visual Systems team is seeking a Visual Designer with strong expertise in icon system design and asset production to join Central Products, an organization supporting the Client brand in product. Our team creates, maintains and evolves the visual systems that define our brand in product surfaces. A designer in this role demonstrates comfort with collaboration and provides a strong creative point of view. The ideal candidate is a multi-faceted, innovative problem-solver, possessing an eye for outstanding creative and pixel perfect work, and the ability to deliver and launch initiatives on time and in alignment with strategic goals. Deep expertise in Communication Design is essential, along with adaptability to various styles and mediums and experience working within product environments. Nice-to-Have Skills: • Experience contributing to a design system. • Familiarity with 3D design and motion/animation. • Understanding of design-to-dev handoff and QA in production environments.

Iconography
Figma
Adobe Illustrator
and Photoshop
vector construction
grid systems
optical alignment

Inventory Coordinator

Engineering
 Maryland
6 Months

Location (mandatory): Lanham, MD • The Repair Coordinator is responsible for the proper receipt and tracking of customer subscriber equipment, primarily 2-way radio communication devices. • This includes receiving deliveries, unpacking boxes, validating data, engaging with customers, and entering device and customer information into the system. • The ideal candidate is: o Goal-oriented o Self-motivated o Detail-focused o Professional in demeanor and communication

Logistics
Inventory
Data entry

Journeyman Electrician

Engineering
 Texas
4 Months

Location (mandatory): Red Oak, TX • Overview: The senior Electrician will be responsible for installations, integration and start-up works of Prefab modular data centers at our Red Oak Factory. • Installations: Conduct electrical installations as part of the assembly process. • Integration Support: Perform integration solutions work within the facility. • Start-Up Works: Assist in the start-up and commissioning of modular data centers. • Working Conditions Environment: Factory setting with adherence to safety protocols.

Electrician
Journeyman license

Quality Engineer II

Engineering
 Texas
06 Months

Location (mandatory): Lewisville, TX Identify technical problems with suppliers and implement corrective actions as well as ensuring structural quality and process improvements. 1 Google meet video on- 2 IV on site- duration 30 min

Manufacturing
Quality Engineering
Six Sigma
Lean Manufacturing

Quality Auditor

Engineering
 California
23
12 Months

Location (mandatory): Chino, CA

QA
QC
Audit
Inspection

Analyzing Technician

Engineering
 Illinois
2 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

Signal Support Specialist

Engineering
 Washington
12 Months

Location (mandatory): Washington, DC This position involves close supervision, detailed instructions, and constant performance checks. The technician will provide post-sale installation and maintenance support for communication products, including:  Hardware installations  Site equipment audits  Customer service response in a break-fix environment  Primary Focus: Mobile and station work associated with Conventional, SmartNet Trunking, and Paging Systems for single-site customers.

RF
Windows
IT Support

Software Engineer – PAT Testing

Engineering
 Massachusetts
8 Months

Location (mandatory): Lexington, MA Designs and implements software of embedded devices and systems from requirements to production and commercial deployment for product lines. Designs, develops, codes, tests, and debugs system software. Involved in specifications, design, and development of embedded firmware in engineering projects. Analyzes and enhances efficiency, stability, and scalability of system resources. Integrates and validates new product designs. Supports software QA. Provides postproduction support. Interfaces with hardware design and development. Experience in embedded systems development. Experience in hands-on development and troubleshooting on embedded targets. Solid programming experience in C or C++. Proven experience in embedded systems design with preemptive, multitasking real-time operating systems. Knowledge of reading schematics and data sheets for components. Strong documentation and writing skills. The Laser Communication Group specializes in designing, prototyping, and testing laser communication systems. Develop solutions to mitigate signal fluctuations caused by vibration, turbulence, and wavefront distortions, with a focus on secure, high-bandwidth communication links. Our key projects include laser communication terminals for ground, air, space, and testing terminals for interoperability with standards. We are seeking a short-term control system developer to join our team in testing Pointing, Acquisition, and Tracking (PAT) systems. This role will involve the designing of testbeds to fully assess PAT systems, developing code to collect data, and analyzing the data.

C++
Matlab
python
PAT testing
logo

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


2025. All right reserved.
logologologologo