Process Engineer

About the Organization By joining the Instant Systems team, you will be at the forefront of innovation in med tech and biotechnology. You will work with innovative companies who are leading the way in creating lifesaving therapies for patients around the world. You will work side by side with your fellow team members to create future innovations for best patient outcomes. We are looking for strategic problem solvers who thrive in an autonomous environment of diverse and energized collaborators. If you are motivated by new challenges and opportunities for skills growth, we welcome you to apply. Your energy and expertise is valuable, spend it making a difference on a worthy mission. Job Summary We are seeking a highly motivated and detail-oriented Process Engineer to join our team. This role is responsible for developing, optimizing, and maintaining manufacturing processes to ensure high-quality production of single use supplies including medical device components. The ideal candidate will have hands‑on experience in a manufacturing environment, with a strong background in process engineering, lean manufacturing, and quality systems within a regulated industry. Responsibilities Develop, implement, and optimize manufacturing processes Troubleshoot and resolve hardware manufacturing, quality and test issues to support production schedules. Provide corrective actions to fix tooling to minimize downtimes Conduct process validation activities including writing and executing IQ/OQ/PQ Improve manufacturing processes, documentation, yield and test efficiency in collaboration with a multi‑disciplined team. Translate engineering design requirements into manufacturing operations sheets, work instructions, tooling and test equipment, workflows and processes. Design, develop, and implement new manufacturing equipment, fixtures, and tools to enhance production capabilities Dispositions non‑conforming material with root cause, corrective action and defect analysis as required to prevent recurrence. Review design drawings for manufacturability and cost (DFM, DFC). Analyze production data to identify trends, inefficiencies, and opportunities for improvement. Collaborate with cross‑functional teams to support new product introductions and process scale‑up. Drive continuous improvement initiatives using Lean, Six Sigma, and other methodologies. Troubleshoot process issues and conduct root cause analysis and corrective/preventive actions (CAPA). Support equipment selection, installation, and qualification. Maintain and update process documentation including SOPs, work instructions, and risk assessments. Ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements. Train production staff on new processes, equipment, and best practices. Monitor and improve process yields, cycle times, and overall equipment effectiveness (OEE). Participate in audits and inspections, providing technical support and documentation as needed. Evaluate and implement automation solutions to improve process reliability and reduce labor costs. Manage small to medium‑scale engineering projects from concept through execution. Other responsibilities as assigned. Qualifications A Bachelor’s degree in STEM A minimum of 5 years of relevant work experience within the medical device or other regulated manufacturing environment. Strong multi‑disciplinary engineering aptitude, analytical skills and problem‑solving skills. Experience with Lean Manufacturing and Continuous Improvement activities Proficiency with CAD modeling tools Strong organization skills with the ability to manage multiple tasks simultaneously. Proficient use of Microsoft Office suite (Excel, PowerPoint, Word) Strong knowledge of lean manufacturing, Six Sigma, and statistical process control (SPC). Experience with validation protocols (IQ/OQ/PQ) and risk management tools (FMEA). Solid company‑centric ideology. Creative problem‑solving skills. Core values of honesty and respect. A thirst for learning. The desire to be challenged. You will thrive if you: Enjoy an autonomous work environment. Have a LEAN mindset. Can be the first person to help. Seek out opportunities to bring added value. Company Benefits & Perks 401K Health Benefits: Medical, Dental, Vision Wellness Program Life Insurance Corporate Sponsored Events Skill growth opportunities Short Term Disability Ability to Advance Working with energetic & creative problem solvers A mission worthy of your energy and expertise Instant Systems’ provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. #J-18808-Ljbffr