Manufacturing Engineer at Techtrueup Indianapolis, IN

Techtrueup; Indianapolis (IN); On-site; USD 75,000 - 95,000; Full time

Job summary

Techtrueup is seeking a Manufacturing Engineer in Indianapolis, IN, for a 6-month contract, focusing on supporting medical device manufacturing processes. The role involves developing validation strategies, ensuring compliance with FDA and ISO standards, and collaborating with cross-functional teams to implement effective solutions.

The ideal candidate will possess strong problem-solving skills, experience with process validations, and knowledge of quality control tools. This position offers an opportunity to contribute to innovative medical device projects.

Qualifications

• Experience supporting medical device manufacturing process validations.
• Knowledge of design control and cGMP requirements.
• Ability to lead and prioritize multiple project assignments.

Responsibilities

• Develops process validation strategies and creates plans.
• Ensures regulatory compliance per FDA and ISO standards.
• Collaborates across teams to implement solutions.

Skills

Process validations for medical devices

Test method validation

Root cause analysis

Quality tools

Cross-functional teamwork

Tools

Microsoft Office Suite

Statistical process control

Job description

Manufacturing Engineer job at Techtrueup. Indianapolis, IN.

Siri InfoSolutions, Inc. is a private equity consortium firm providing IT staffing services to Fortune 500 clients across the US. We believe that it’s an exceptional company – a company of people proud of the work they do and the solutions they provide. By understanding what drives our specialty industries, becoming involved in our communities in a professional and personal capacity, following a disciplined process of identifying quality candidates, partnering with employers to understand their core business and employment requirements, and delivering exceptional service, we achieve great results for all concerned. Professional Services: – Contract Staffing – Direct placements – Bench Sales – Application Development – Enterprise Resource Planning – Data Warehousing – Customer Relationship Management. Siriinfo provides services to a wide spectrum of customers across verticals such as Banking, Financial Services, Healthcare, Human Resources, Telecom, Insurance, Hospitality, Retail & Distribution and Manufacturing. Serving multinational customers. Siri InfoSolutions reinforces its belief that the quality of our services can only be measured by the skills, performance and dedication of our employees. We will place only the very best candidates for our clients – candidates who are not only willing, but who possess the necessary skills to do the job effectively.

Job Description

Role: Manufacturing Engineer

Location: Warsaw, IN

Duration: 6 Months

Qualifications

• Experience supporting medical device manufacturing process validations, specific experience with process characterization, equipment IQOQ, process OQ, and PQ.
• Specific experience with test method validation and Gage RR. Experience with root cause analysis and problem‐solving for both technical and process issues.
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO 13485-2003.
• Ability to lead and prioritize multiple medium‑complexity project assignments and complete work in a timely manner.
• Good problem‑solving skills using quality and statistical tools, BOM router creation and update.
• Ability to read and understand engineering drawings.
• Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical‑to‑Quality (CTQ) analysis.
• Knowledge of quality system requirements, ISO and FDA requirements.
• Ability to effectively work within a cross‑functional team and demonstrate good written and verbal communication skills.
• Experienced with control procedures, such as the change management system, nonconformance reports, engineering specifications, CAPA, and work instructions.
• Proficient with statistical process control concepts and Microsoft Office Suite and Project.

Roles & Responsibilities

• Develops and executes process validation strategies, creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective processes for medical devices and equipment.
• Ensures regulatory compliance, adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up‑to‑date knowledge.
• Analyzes data and writes comprehensive reports, identifying trends for process improvement.
• Collaborates cross‑functionally with manufacturing, QA, engineering, and other teams to implement cleaning strategies, resolve issues, and provide technical support.
• Leads continuous improvement initiatives, manages change controls, troubleshoots cleaning problems, and ensures proper documentation and training.
• Creates, maintains, and improves controlled technical documents such as prints, procedures, bills of materials, and routers.
• Supports a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, and molding.
• Conducts feasibility studies to estimate product cost, analyze capital equipment, capacity and capability requirements; establishes and improves process methods that meet performance and quality requirements.
• Develops and executes project plans and schedules for work activities; communicates direction and project plans with appropriate personnel from other departments.
• Evaluates multiple options to select the most appropriate processes and machining methods.
• Executes equipment qualification or process validation projects.

EEO Statement

All your information will be kept confidential according to EEO guidelines.