Manufacturing Engineer II

SGS_JOB_1020

Engineering
 Massachusetts
FDA
OSHA
ISO requirements
Lean Manufacturing/Six Sigma or Black Belt
Manufacturing Equipment
Project Management
Validation Plans/Validation Protocols
Validation Plans/Validation Protocols
Change Control/CAPA

Contract - 06-08 Months+

Onsite position To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Maintain and support new and existing Operations Equipment Understand and be knowledgeable of Equipment and Process Operations completed in the facility. This includes site SOPs, Equipment documentation, capacity, setup, operation, disassembly, maintenance, cleaning, troubleshooting, monitoring, and programming of manufacturing equipment and facility. Perform testing and troubleshooting on equipment to determine functionality level and capacity. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Job Responsibilities:

  • Create, update, and maintain equipment service work instructions.
  • Organize and write validation protocols associated with the manufacturing process
  • Lead and support troubleshooting activities to minimize process downtime or re-occurrence
  • Identify key process indicators and collect data to drive manufacturing and yield improvements
  • Responsibilities: Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices.
  • Provide statistical analysis of the date to support the reports.
  • Generation and implementation of change controls and engineering notices (ECO).
  • Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
  • Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs.
  • Evaluate, investigate, and document non-conformances incidents and/or protocol deviations.
  • Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
  • Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
  • Work on project teams with other internal departments, external vendors, and customers as required.
  • Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
  • Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary.

Skills:

  • FDA, OSHA, ISO requirements
  • Lean Manufacturing/Six Sigma or Black Belt
  • Manufacturing Equipment
  • Project Management
  • Validation Plans/Validation Protocols
  • Change Control/CAPA

Education/Experience:

  • BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.
  • Lean/Six Sigma Green or Black Belt Certification is a plus.
  • Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.

Related Jobs

Material Coordinator

Engineering
 Iowa
01 Years (Possible Extension)

Location - Ankeny, IA 50023. We are seeking a detail-oriented and proactive individual to join our team in the BC Role. This position combines technical expertise with strong organizational and communication skills to ensure smooth operations and timely delivery of critical parts Shift: 1st Shift – Monday to Friday (Flexible start at 6:00 AM) Overtime: Possible based on business needs

Manufacturing
Industrial
Engineer

Linguist III

Engineering
 Washington
06 Months

Location : Redmond, WA or Burlingame, CA (Onsite) Pay Rate : 50-60/Hr. on W2 We are looking for a Linguist to help us develop language components for a variety of voice-enabled technologies and products. We are seeking candidates with strong linguistic data analysis and language technology experience to manage data collection, LLM-powered data synthesis and data annotation tasks, prompt engineering, rule-based classifier encoding, and quality evaluations.

Computational Linguistics
SQL
Python
NLP
NLU
LLMs
ML
Conversational Assistant
RegEx

Data Analyst III - Operations

Engineering
 Texas
$70-80/Hr.
17 Months

Location : Forth Worth, TX(Onsite) Client's Site Operations team is seeking an Operations Data Analyst to help drive operational excellence by analyzing capacity, uptime, and performance across our data centers. This role is critical for enabling leadership to make informed decisions, optimize strategies, and ensure our infrastructure is running at peak efficiency. You’ll work closely with operations, engineering, and data science partners to deliver actionable insights, maintain reporting code, and develop dashboards that support our core KPIs.

Analytics
SQL
Python
operations
data center
Dashboards
Tableau
Bento
Manufacturing
telecom
or NOC environments.

Data Analyst IV - PLM

Engineering
 California
$80-95/Hr.
06 Months

Location : Sunnyvale, CA (Onsite) As Product Configuration Analyst you will take on a critical role in bringing AR/VR to our customers. You will work side-by-side with engineering and business teams that are leading innovation in this exciting new product category. Under supervision, the Product Configuration Analyst will support a variety of product projects through the entire product lifecycle. You must be flexible, responsive, and able to manage competing demands.

PLM
PCBA
Teamcenter
Agile PLM
Arena
or Enovia
BOM
NX
Cadence

Quality Engineer II

Engineering
 Massachusetts
6 Months + (Possibilities of Contract Extension)

Location : Marlborough MA USA 01752 We are seeking The Quality Engineer II is responsible for validation of analytical methods, cleaning, production process, equipment qualification, facilities/utilities qualification, and raw materials qualification.

Quality engineer
validation
FDA
CFR
ISO
FMEA

Digital Publisher

Engineering
 Illinois
01 Years (Possible Extension)

Location (mandatory): Moline, IL USA 61265 (Remote) Manages project timelines and coordinates tasks to ensure the successful launch and timely publishing of web content across platforms.

PIM
Tools

Design Assurance Engineer

Engineering
 Colorado
06 Months

Location : Louisville CO USA 80027 We are looking for the Design Assurance Engineer who will providing design assurance support for new product development and on market medical devices. This role will be responsible to facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts

FDA Quality System Regulations
especially Design Control requirements
ISO 13485 and Medical Device Directive

Video Production & Digital Asset Coordinator

Engineering
 Illinois
03 Years + (Possible Extension)

Location (mandatory): Moline, IL USA 61265 Join our C&F Marketing Communications team to create impactful video content that connects with customers, dealers, and employees. This role combines creativity and organization, supporting our sales and marketing organization and factory teams through high-quality video production and asset management.

Video
Editing

Repair Technician II

Engineering
 Florida
06 Months

Location : Orlando, FL. Shift Hours 8:00 am to 4:30 pm Shift Days Monday - Friday We are seeking a skilled and detail-oriented Repair Technician to join our team, specializing in radio communications equipment. The ideal candidate will have hands-on experience in depot-level radio repair, troubleshooting, upgrades, and programming. This role requires a strong understanding of telecommunications systems, mechanical aptitude, and proficiency with diagnostic tools and software.

Repair
Test
Lab equipment
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