Senior Systems Engineer - Hardware/Software Integration

TechDigital Group; Marlborough (MA); On-site; USD 113,652 - 161,868; Full time

Job summary

An established industry player is seeking a specialist to join their team as a system architect. In this role, you will utilize your significant domain knowledge to manage requirements and design systems of moderate complexity. You will collaborate across functions to deliver high-quality products while mentoring engineers and leading project teams. This position offers the opportunity to make impactful decisions that affect cost, schedule, and technical performance in a dynamic environment. If you are passionate about innovation and eager to drive continuous improvement in systems development, this is the perfect opportunity for you.

Qualifications

• Bachelor's Degree in Engineering or Science or equivalent experience.
• Significant domain knowledge in related products and systems.

Responsibilities

• Serve as a system architect to manage requirements and design systems.
• Lead cross-functional teams to define and implement new products.

Skills

System Architecture

Project Management

Domain Knowledge

Technical Documentation

Cross-Functional Collaboration

Education

Bachelor's Degree in Engineering or Science

High School Degree with 8 years experience

Tools

Project Management Tools

Job description

Job summary :
Quality Engineer with 5+ years of experience in the medical device industry, specializing in quality, validation, and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root cause investigation, and new product commercialization. Strong analytical, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality, compliance, and continuous improvement initiatives.


Roles & Responsibilities:
• Experience in a GMP and/or ISO regulated medical industry is required.
• Ability to analyze and present data that facilitates & drives decision making is required.
• The ability to perform "hands on" troubleshooting and problem solving is required Experience working in an FDA regulated environment is preferred.
• Experience working in operations supporting a production environment is preferred Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. Measurement System Analysis, SPC, DOEs, Reliability, etc.) is preferred
• Technical understanding of manufacturing equipment and processes is preferred Process Validation expertise is preferred.
• Ability to read and interpret CMM and dimensional inspection reports.
• Experience with dimensional data analysis utilizing software (Excel or Minitab)
• Experience in Medical Standards and Quality process preferred.
• New product launch experience from through full validation and commercial launch
• Experience with PFMEA/DFMEA's, Gage R&R's, TMV's, Risk Assessments and Control Plan
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• Performance Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components.
• Strong communication skills and ability to work well within a multidisciplinary team.
• Proficient with GD&T and interpreting technical drawings.
• Green or Black Belt Six Sigma certification preferred.

Top Skills:
• Process Validation & Quality Engineering (IQ/OQ/PQ, TMV, PFMEA, Gage R&R)
• Statistical Analysis & Six Sigma (SPC, DOE, MSA, Minitab)
• Medical Device Quality Systems (GMP, ISO 13485, FDA Compliance)

Additional Information:
• Bachelor in Mechanical Engineering or equivalent and have min. 5 years' experience working as a Quality, Validation and or Manufacturing Engineering role in a Medical Product industry required.
• Required medical domain experience. Surgical Product and Implants experience preferred.