Manufacturing Engineer View Details Full Time NEW

Exercises technical leadership and analytical skills in the resolution of production issues. Demonstrates creativity in implementing process improvements and new manufacturing methods including the conception, design and implementation of new tools, fixtures, and software. Prepares technical reports, draft and executes process/software validations. This position would be responsible to closely work with design & mechanical engineers to provide necessary support by applying theory and principles of mechanical engineering to develop, assemble, modify, test and/or calibrate prototype products, machinery and test equipment under the direction of Manufacturing Engineering management staff.

Duties And Responsibilities

• Review prototype, test instructions and schematics to ascertain test specifications, procedures, and objectives.
• Interpret engineering prototypes, test instructions, and schematics to identify, modify and plan requirements for fabrication, assembly, testing and test nature of technical problems.
• Actively participate on new product release teams from the earliest phases to assure that 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 PFMEA’s.
• Devise, fabricate and assemble new or modified assembly and test fixtures using appropriate machine shop and/or hand tools or software modules.
• Apply DOE and statistical tools to identify root cause(s) of yield loss and propose and implement corrective actions, make recommendations for changes in test fixtures or test methods by applying theory & principles of mechanical engineering.
• Maintain Work Instructions, BOM’s, preventative maintenance schedules, and Routers.
• Record test procedures and results; write test reports using numerical and graphical data using Excel and Word.
• Confer with engineering staff and submit reports of test results to engineering department and recommend design or material changes.
• Actively participate in discussions related to changes in design, method of manufacture and assembly, and drafting techniques and procedures with staff and coordinate corrections.
• Document software specifications for review prior to development of software.
• Develop and release software in a controlled manner, ensure developmental software is not active prior to validation and release.
• Identify and resolve manufacturing errors expeditiously with attention to impact on safety/ergonomics, quality, cost and production schedules from software.
• Perform other work-related duties as requested, directed or assigned by management.

Education and Experience

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

Conducts, maintains, tests and repairs electrical/electronic, mechanical systems and components. Applies knowledge of electrical/electronics and mechanical principles in determining equipment malfunctions and applies skills in restoring equipment to operation. Duties and Responsibilities

• Repair and calibration of precision medical flow sensors; recirculation and test of flow meters.
• Troubleshoots and repairs mechanical and electrical/electronic equipment including but not limited to programmable controls, numeral controls, gages and test equipment.
• Sets-up and operates a variety of hand-operated tools and electronic equipment to manufacture product specified on work orders using standard work instructions and Inspection procedures.
• Documents inspection results and enters data into the devices database and other computer collection systems.
• Plans and performs work requiring a thorough knowledge of electrical/electronic and mechanical theories and principles, writing specifications, local and national electrical codes, properties of various materials, and principles of operation and application of electronic equipment.
• Maintains company-required performance and maintenance records for identified equipment.
• Orders parts as required in order to complete repairs.
• Performs preventive maintenance functions as directed.
• Assists manufacturing personnel with technical troubleshooting.
• Ensures clean and organized work environment at all times.
• Manage tasks related to multiple production duties, prioritize and respond to special assigned duties.
• Other tasks as assigned by the Dept. Manager.

Education and Experience

• High school diploma or its equivalent required.
• Two-year technical degree or equivalent work experience in a technical field is preferred.
• Minimum of 2years of calibration experience preferred and the ability to demonstrate high proficiency in these areas.

This position is responsible for the design, development, verification, and lifecycle support of electronic systems used in Transonic’s medical devices and life science instrumentation.

As part of a small and highly collaborative engineering team, this role will support:

• New product development
• Sustaining engineering and obsolescence management
• Cost and manufacturability improvements
• Verification and validation activities aligned with medical device design controls

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.

Duties And Responsibilities

• Design and develop analog, RF, and digital circuits for medical devices
• Design and review analog and digital PCB layouts
• Troubleshoot analog and RF circuits to the component level
• Develop test methods and verification protocols for electronic PCB assemblies
• Perform verification testing to confirm design performance and compliance
• Evaluate and improve existing PCB assemblies for reliability, cost, and manufacturability
• Support component selection, supplier changes, and obsolescence mitigation
• Create and maintain design documentation, drawings, specifications, and ECOs
• Support root cause investigations and corrective actions as needed
• Collaborate cross-functionally to support regulatory submissions and audits
• Perform additional engineering tasks as assigned

Education and Experience

• 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

This position is responsible for all Clinical & Hemodialysis product and service sales activities, from lead generation through close of sale, in an assigned territory. Selling of products and services includes using technical, organizational, and customer knowledge to influence customers and assist them in applying the products/services to their needs. This position works in cooperation with the sales, marketing and support team for the achievement of customer satisfaction, revenue generation, and sales goals in alignment with Company vision and values.Duties and Responsibilities

• Conduct presentations to demonstrate, answer questions and sell clinical and hemodialysis products and services to existing and potential customers within the assigned territory to reach sales goals.
• Prepare effective business plans and schedules to identify specific targets in assigned territory
• Identify sales prospects and contact these and other accounts promptly and as assigned.
• Contact customers in assigned territory to demonstrate products, explain product features and advantages and solicit orders
• Follow up, in a timely manner, on new leads and referrals resulting from field, internal leads (HubSpot) and tradeshow activity
• Answer customers’ questions about products, promotions, pricing, availability, product uses, and credit terms.
• Research customer needs and develop application of products/services in an effective manner resulting in recommendation of products to customers based on customers’ needs and interests.
• Demonstrate and utilize most current product knowledge and technical selling skills in current product lines.
• Continuous and on-going consulting with customers after sales or contract signings to grow business and to provide ongoing support.
• Identify, respond and resolve customer concerns promptly and professionally
• Participate in marketing events such as seminars, trade shows and conferences and assist in the implementation of Transonic marketing plans as needed.
• Communicate new product and service opportunities, special developments, information or feedback gathered through field activity to Regional Sales Manager.
• Maintain accurate records of all sales and prospecting activities including sales calls, presentations, closed sales, and follow up activity within Transonic CRM system
• Establish, develop and maintain professional internal and external relationships that meet Company core values.
• Monitor Sales expenses to plan
• Perform other work-related duties as requested, directed or assigned by management.

Education and Experience

• Bachelor’s degree in Business, Life Sciences, or related field required.
• 3-5 plus year’s selling experience required
• Valid driver’s license required
• Sales experience in capital equipment, operating room sales, dialysis and technology within the medical device space is strongly preferred
• Sales experience to surgeons within the cardiovascular space, vascular space, neurological space and microvascular space a plus.