Afternoon Medical Device Startup Jobs in Indiana

POSITION SUMMARY

The Manufacturing Engineer is responsible for the industrialization, development, implementation, validation and optimization of manufacturing processes for electrical and mechanical assembly and fabrication operations. This role leads and supports new product introduction (NPI) and the transition of products from design into production, ensuring manufacturing processes are robust, repeatable, scalable and efficient.

The Manufacturing Engineer works hands-on with production teams on the manufacturing floor to develop and improve processes, troubleshoot production issues, design and implement tooling and fixtures, support equipment installation and startup, establish process controls and implement automation solutions. Working cross-functionally with engineering, quality, supply chain and production teams, this position drives production readiness, process capability, continuous improvement, product quality, safety, throughput and cost efficiency.

POSITION GUIDELINES

• Effective interpersonal and team leadership skills.
• Able to solve complex problems.
• Good verbal and written communication skills.
• Sound judgement and decision making.
• Ability to communicate and implement change. 

JOB DUTIES & RESPONSIBILITIES

• Lead new product introduction (NPI) and industrialization activities, ensuring successful transfer of products from design into production.
• Work directly on the production floor with operators and production teams to develop, implement, troubleshoot and improve manufacturing processes.
• Design, develop, and implement manufacturing fixtures, tooling and assembly processes for electronics and mechanical assemblies.
• Work with operators, vendors and tool designers to develop tooling designs and implement the tooling with operators on the production floor.
• Support hands-on manufacturing operations involving soldering, epoxy dispensing, electromechanical assembly, tooling, fixtures and related manufacturing processes.
• Support the installation, setup, qualification, validation and production startup of new manufacturing equipment and capital projects.
• Analyze and optimize manufacturing processes to improve production efficiency, quality, safety, capacity and cost performance.
• Perform root cause analysis and failure investigations and implement corrective and preventive actions (CAPA) to resolve manufacturing and quality issues.
• Identify and implement automation solutions to improve manufacturing throughput, consistency and product quality.
• Develop, document, validate and maintain manufacturing procedures, work instructions, process flows and engineering documentation.
• Establish process controls, collect and analyze production data, develop labor standards and monitor key manufacturing metrics.
• Develop and maintain APQP documentation, including Process Flow Diagrams (PFD), PFMEA, Control Plans, MSA studies and process validation protocols.
• Conduct capability studies and equipment/process qualifications, including IQ, OQ and PQ activities.
• Lead continuous improvement initiatives utilizing Lean Manufacturing, Six Sigma, Kaizen, 5S, SPC and other operational excellence methodologies.
• Collaborate with production, quality, supply chain, engineering, vendors and customers to resolve technical issues and improve manufacturing performance.
• Support compliance with ISO 9001, ISO 13485 and applicable regulatory requirements.
• Perform other duties as assigned.

QUALIFICATIONS

Experience/Background

• Minimum 5 years of Manufacturing Engineering experience in a production environment.
• Medical device manufacturing experience preferred.
• Experience supporting mixed electrical and mechanical assembly.
• Hands-on experience with processes including soldering, epoxy application, tooling, fixtures and manufacturing equipment.
• Experience with process validation, process control and manufacturing documentation systems.
• Proven success leading continuous improvement and cost reduction initiatives.
• Experience supporting high-volume manufacturing environments preferred.
• This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR). This position requires individuals who are U.S. persons or protected individuals within the meaning of ITAR. ITAR defines U.S. persons and protected individuals as a U.S. Citizen, U.S. Permanent Resident (i.e., 'Green Card Holder'), U.S. Temporary Resident, Political Asylee, or Refugee. 

Skills

• Lean Manufacturing and Six Sigma methodologies.
• APQP, PFMEA, Control Plans, SPC, MSA, CAPA, and Root Cause Analysis.
• Process validation methodologies including IQ/OQ/PQ preferred.
• Manufacturing automation and equipment integration.
• ERP/MRP systems and production planning tools.
• CAD software experience; SolidWorks preferred.
• Statistical analysis and process capability evaluation.
• Microsoft Office Suite proficiency.
• Strong problem-solving capabilities.
• Proficient in English (reading, writing & verbal skills)
• Effective interpersonal skills to drive tasks to completion

Education

• Bachelor of Science in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related technical discipline.
• Equivalent combination of education and relevant engineering experience will be considered.

ENVIRONMENTAL & PHYSICAL REQUIREMENTS

Manufacturing / Non-Sedentary Requirements

Incumbent must be able to perform the essential functions of the job. Work may be performed in an office or warehouse environment. Typically requires the ability to spend 66%+ hours each work day doing the following activities: stand for extended periods of time, walk, bend, stoop, or climb.  May have possible exposure to dust, and may require the ability to lift and/or push up to 50 pounds 33% - 66% of the time.

ADDITIONAL INFORMATION REGARDING JOB DUTIES AND JOB DESCRIPTIONS

Job duties include additional responsibilities as assigned by one’s supervisor or another manager related to the position/department. This job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. Piezo Technologies reserves the right at any time with or without notice to alter or change job responsibilities, reassign or transfer job position or assign additional job responsibilities, subject to applicable law.  Piezo Technologies shall provide reasonable accommodations of known disabilities to enable a qualified applicant or employee to apply for employment, perform the essential functions of the job, or enjoy the benefits and privileges of employment as required by the law.