Engineer

Engineer II, Manufacturing

Top requirement: Role Highlights • Engineer II role supporting FDA-regulated medical device manufacturing. • Position will focus on manufacturing and process support, including validation activities. • Bachelor's degree in Engineering required; target experience range of 2–4 years +. • Validation experience (IQ/OQ/PQ) strongly preferred.

Interview & Location Notes • In-person interviews preferred where feasible. • Role is onsite with a temporary split between Gary, IN and Highland, IN during facility transition. • Permanent work location expected to be Highland, IN following relocation completion.

Key Takeaways • Prioritizing candidates with regulated manufacturing experience. • Hiring timeline is accelerated due to business need. • Strong performers may be considered for longer-term opportunities.

The Engineer II, Manufacturing is responsible for supporting manufacturing process improvements through adherence to established design control processes, good engineering and documentation practices. The key responsibility of this position is to support and sustain production. The Engineer II will complete intermediate projects with guidance from more experienced engineers and managers. They gain exposure to some of the complex tasks within the job function and are occasionally directed in several aspects of the work.

Quals-- Essential Duties & Responsibilities • Immediate expectations: o Under the guidance of the Engineering leadership, work to improve performance of manufacturing systems, e.g. OEE improvement (quality, performance and uptime), maintenance needs, MUV and scrap reduction o Support project timelines and milestones and bring them to completion on time and within budget o Assist in completion of CAPA tasks and deliverables (Corrective and Preventive) o Use methodical approach for root cause analysis and propose robust technical solutions o Process technical expert for a manufacturing production line o Create and edit documents to support Production o Support initiatives for continuous process and product improvements o Conducts independent analysis and develops solutions to problems. o Develops approaches and designs where precedent usually exists. o Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design o Receives general project direction. Solicits input from more experienced engineers. o Work on special projects as they arise • Long term expectations: o Initiate and manage projects with adherence to program-management guidelines o Develop innovative tool design improvements o Develop and characterize processes and summarize technical details o Work with Quality Engineers on qualification activities for new or modified processes and equipment. o Assists in training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. o Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.

Knowledge & Skills • General understanding of automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques • Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) • Knowledge of the Medical Device Industry and familiarity with FDA QSR Regulations - preferred • Proficiency in SolidWorks. Mechanical understanding, tool design experience • Technical writing competency • Competent in your domain. Familiar with other areas of domain expertise within the team. • Has a basic understanding of best practices. Has a basic to intermediate understanding of engineering discipline • Have awareness of the broader product strategy and contribute to it • Ability to receive general project direction and solicit input from more experienced engineers. • Requires the ability to independently make decisions that impact the attainment of project objectives.

Minimum Qualifications, Education & Experience •Must be at least 18 years of age •Bachelor's degree from an accredited college or university (Engineering, Technology, or STEM)