Development and Security Operations (DevSecOps) Engineer View Details

Multiple engineering and operations roles are available. Below are the detailed descriptions for each position.

Manufacturing Engineer

Responsibilities

• Exercises technical leadership and analytical skills in the resolution of production issues.
• Demonstrates creativity in implementing process improvements and new manufacturing methods, including conception, design, and implementation of new tools, fixtures, and software.
• Prepares technical reports, drafts, and executes process/software validations.
• Provides support to design and mechanical engineers by applying theory and principles of mechanical engineering to develop, assemble, modify, test, and/or calibrate prototype products, machinery, and test equipment.
• Reviews prototype, test instructions, and schematics to ascertain test specifications, procedures, and objectives.
• Interprets engineering prototypes, test instructions, and schematics to identify, modify, and plan requirements for fabrication, assembly, testing, and test nature of technical problems.
• Actively participates on new product release teams from the earliest phases to ensure design-for-manufacturing concepts are employed and to facilitate a smooth transition from Engineering to Manufacturing.
• Owns the development of assembly processes for new products as well as the introduction of new methods into the assembly processes of current products and associated PFMEAs.
• Devises, fabricates, and assembles new or modified assembly and test fixtures using appropriate machine shop and/or hand tools or software modules.
• Applies DOE and statistical tools to identify root cause(s) of yield loss and proposes and implements corrective actions.
• Makes recommendations for changes in test fixtures or test methods by applying theory and principles of mechanical engineering.
• Maintains Work Instructions, BOMs, preventative maintenance schedules, and Routers.
• Records test procedures and results; writes test reports using numerical and graphical data in Excel and Word.
• Confers with engineering staff and submits reports of test results to the engineering department, recommending design or material changes.
• Actively participates in discussions related to changes in design, method of manufacture and assembly, and drafting techniques and procedures with staff, coordinating corrections.
• Documents software specifications for review prior to development of software.
• Develops and releases software in a controlled manner, ensuring developmental software is not active prior to validation and release.
• Identifies and resolves manufacturing errors expeditiously with attention to impact on safety/ergonomics, quality, cost, and production schedules from software.
• Performs other work-related duties as requested, directed, or assigned by management.

Qualifications

• BS in Mechanical, Manufacturing, or Biomedical Engineering required; MS in Mechanical or Biomedical Engineering preferred.
• Minimum of two years' experience; prior experience in the medical device industry and familiarity with FDA CGMP regulations preferred.
• Proficiency in 3D Modeling required.
• Proficiency in LabVIEW programming preferred.
• Experience in systems design.

Electrical Engineer

Responsibilities

• Designs and develops analog, RF, and digital circuits for medical devices.
• Designs and reviews analog and digital PCB layouts.
• Troubleshoots analog and RF circuits to the component level.
• Develops test methods and verification protocols for electronic PCB assemblies.
• Performs verification testing to confirm design performance and compliance.
• Evaluates and improves existing PCB assemblies for reliability, cost, and manufacturability.
• Supports component selection, supplier changes, and obsolescence mitigation.
• Creates and maintains design documentation, drawings, specifications, and ECOs.
• Supports root cause investigations and corrective actions as needed.
• Collaborates cross-functionally to support regulatory submissions and audits.
• Performs additional engineering tasks as assigned.

Engineers at Transonic gain broad exposure to the full development lifecycle — from user needs and design inputs through verification, regulatory documentation, production transfer, and post-market support.

Qualifications

• Bachelor’s Degree in Electrical Engineering or a related field required.
• 2-3 years' experience preferred.
• Experience with programs for schematic capture, PC board layout, CAD, and database programs.
• Experience with microcontroller programming and FPGA programming is a plus.
• Experience in regulated industries (medical device preferred) is a plus.

Quality Engineer

Responsibilities

• NCMR Process Owner:
  • Serves as the primary Quality representative and process owner for the company’s Nonconforming Material Report (NCMR) program.
  • Provides guidance on Quality System requirements, investigation expectations, risk evaluation, disposition decisions, documentation, and timely closure.
  • Leads and coordinates cross-functional failure investigations involving nonconforming materials, components, assemblies, and finished products.
  • Ensures nonconforming materials are appropriately identified, contained, evaluated, dispositioned, and documented.
  • Facilitates daily cross-functional NCMR review meetings to prioritize newly opened NCMRs, review investigation and disposition status, address overdue actions, and assign follow-up activities.
  • Drives timely and effective closure of NCMRs.
  • Works closely with Manufacturing, Engineering, Manufacturing Engineering, Planning, Repair, Quality Assurance, and other stakeholders to support investigation and disposition decisions.
  • Ensures NCMR records are complete, accurate, appropriately approved, and maintained in accordance with applicable Quality System and regulatory requirements.
  • Supports root cause analysis and ensures investigation conclusions are supported by appropriate evidence and documented rationale.
• Quality Data, Trending, and Reporting:
  • Analyzes NCMR, failure investigation, deviation, and related quality data to identify trends, recurring issues, and emerging risks.
  • Recommends opportunities for corrective action, preventive action, process improvement, supplier follow-up, or CAPA initiation.
  • Develops and maintains meaningful NCMR metrics and key performance indicators.
  • Prepares and presents Management Review information related to NCMRs, failure investigations, deviations, ECO activities, and other assigned Quality System processes.
  • Communicates significant trends, risks, and recurring quality issues to Quality leadership and appropriate process owners.
• Additional Quality System Support:
  • Supports the monitoring and review of applicable standards and regulatory requirements, including ISO 13485, FDA requirements, EU MDR, MDSAP, and other applicable Quality System expectations.
  • Communicates relevant standards or regulatory updates to Quality, Regulatory Affairs, Engineering, Manufacturing, and leadership teams.
  • Assists in evaluating the potential impact of new or revised standards and regulatory expectations on Quality System procedures, records, processes, and product-related activities.
  • Provides backup support for ECO activities, including technical and quality review, ECO scoping, documentation follow-up, implementation task tracking, and verification of completion and closure.
  • Provides backup support for the deviation process, including documentation, routing, impact assessment, review follow-up, action tracking, and closure.
  • Helps ensure deviations are appropriately justified, reviewed, approved, implemented, and closed in accordance with Quality System requirements.
  • Supports the company’s Safety Data Sheet program, including maintaining applicable records within the Quality Management System.
  • Supports CAPA activities associated with NCMRs, including investigation, root cause analysis, implementation of corrective actions, and effectiveness verification.
  • Participates in internal and external audits by supporting audit preparation, record review, auditor requests, audit responses, and follow-up activities.
  • Supports minor internal audits, including audit planning, execution, documentation of results, identification of observations or opportunities for improvement, and corrective action follow-up.
  • Identifies Quality System gaps and supports continuous improvement initiatives that strengthen compliance, documentation, process effectiveness, and operational performance.
  • Provides additional Quality Assurance support as assigned by management.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical field required.
• 3+ years of experience in quality engineering, quality assurance, nonconforming material review, or regulated manufacturing preferred.
• Prior experience in a regulated environment, preferably medical device, ISO 13485, FDA, MDR, MDSAP, or similar regulated industry, is preferred.

Stockroom Team Member

Responsibilities

• Receiving Materials:
  • Counts packages and signs for materials.
  • Receives all material with POs into the computer system (currently Macola).
  • Delivers direct material requiring inspection to the inspection area; delivers all other direct material to the stockroom.
  • Delivers packages addressed to a person or department to the appropriate area.
• Shipping Products (Sales Revenue):
  • Receives the products from manufacturing physically and into inventory, reviews customer’s order for completeness and accuracy, properly boxes and ships using the designated carriers.
  • Ships the product using vendor-supplied software; freight, UPS, FedEx.
  • Records the transaction in the ERP system.
  • Creates all export documentation necessary for export shipments.
  • Maintains a neat and orderly area.
  • Works effectively and efficiently with great attention to detail.
  • Reviews daily reports for shipping requirements and communicates as necessary.
  • Maintains the Liability and Warranty Module for Shipping/Receiving Equipment.
• Process Repairs (RMAs):
  • Processes Repairs (RMAs) (returned from the customer) within the same business day.
• Maintains safe handling practices when handling any and all products and equipment.
• Performs cycle counts and maintains inventory accuracy.
• Performs other work-related duties as requested, directed, or assigned.

As a member of the Stockroom Team, this individual is expected to have strong communication skills, attention to detail, and a willingness to learn and suggest improvements/changes as needed. The overall responsibility is to maintain