Manufacturing Quality Engineer

About the Role:

Infinite Biomedical Technologies (IBT) designs and manufactures Class II electronic medical devices including prosthetic control systems that have helped over 6,000 people in 46 countries operate their prosthetic arms. We are a small, fast-moving team in downtown Baltimore, and demand for our flagship Glide control system is growing. We are hiring the engineer who owns how our products get built right the first time.

This is a quality engineer who sits in production and owns the engineering of quality. Your responsibilities include supplier quality, nonconformances, CAPA investigation, inspection and sample design, and the process engineering that turns production data into shorter lead times and higher throughput. You will also be a qualified approver for inspection dispositions, the design-transfer partner to our product development engineer, and the person who reports quality and production performance to management each month.

You will have real ownership from day one. We are scaling manufacturing of an electromechanical medical device, and we want the person who makes our supply chain and our production floor predictable, measurable, and continuously better.

Supplier quality

· Own the Approved Supplier List, critical-supplier evaluations and re-evaluations, and supplier corrective action requests

· Design incoming inspection methods and sampling plans; run first-article and ongoing process-capability assessments for cable assembly, PCB assembly, and mechanical suppliers

· Be the technical interface to suppliers on quality matters, through to verified resolution

· Contribute to supplier quality agreements and supplier development plans

Nonconformance and CAPA

· Investigate nonconformances and field-reported issues to root cause; own corrective actions through effectiveness verification

· Serve as qualified approver for inspection records and disposition authority on nonconforming material, within the QMS procedures owned by QA/RA

· Partner with Operations on complaint handling, providing the technical investigation behind each record

Process engineering for production

· Build the statistical rationale for a risk-based inspection strategy grounded in process data

· Track yield, scrap, and rework; identify and eliminate recurring defect sources

· Conduct time studies and work with the Production Manager to reduce build lead time and increase capacity

Design transfer

· Set up material controls and perform production validation of new parts and builds during design transfer, working alongside the Product Development Engineer, who owns DFM and work instructions

· Evaluate work instructions and build processes for efficiency, inspectability, and error-proofing, and recommend optimizations to the Product Development Engineer and Production Manager; support design transfer for upcoming cable assembly and controller component revisions

Reporting and systems

· Own the monthly management review package: statistical and trend analysis of nonconformances, CAPAs, complaints, and supplier performance, plus yields, lead time, and COGS inputs

· Serve as functional lead for our MRP implementation (item master, cycle-count discipline, inventory accuracy)

Required Qualifications

· 3 years in a regulated manufacturing environment - medical device (ISO 13485 / FDA 21 CFR 820), or electronics assembly to IPC standards

· Led nonconformance or CAPA investigations to root cause, including effectiveness verification — not participation, ownership

· Hands-on supplier quality experience: supplier corrective actions, incoming inspection, first-article or supplier qualification

· Working command of statistical quality methods: sampling plans (ANSI/ASQ Z1.4 or equivalent), process capability, SPC

· Bachelor's degree in engineering or a related technical field, or equivalent demonstrated experience

Nice to Have

· Electronics assembly literacy: PCB assembly, cable and harness assembly, IPC-A-610 / IPC/WHMA-A-620

· Design transfer / DFM experience with a product development team

· ISO 14971 risk management; complaint handling and MDR determination

· Drafting or administering supplier quality agreements

· eQMS experience (Greenlight Guru or similar)

· ERP/MRP implementation or inventory-accuracy programs

· CQE, Six Sigma Green/Black Belt, or equivalent

· Experience in a company under 50 people, where you owned outcomes rather than a slice of a process

Compensation and Details

· Full-time, in-person at our Baltimore office (8 Market Place, Suite 500).

· 401(k) with 6% match

· Generous vacation package

· 100% health, dental, and vision coverage

· Annual professional development costs covered by IBT

· Parking reimbursement and other in-office related benefits

Be part of a mission-driven team transforming lives through prosthetic technology. Apply at careers@i-biomed.com or through the posting link. Please include one paragraph describing a nonconformance or supplier problem you personally investigated to root cause and what changed as a result.

Pay: $95,000.00 - $115,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Relocation assistance
• Vision insurance

Application Question(s):

• Which of the following have you applied in a work setting (not coursework)? Select all that apply.
• Sampling plans (ANSI/ASQ Z1.4, c=0, or equivalent)
• Process capability (Cpk / Ppk)
• SPC / control charts
• Measurement system analysis / gauge R&R
• None of these (decline)
• Describe one nonconformance or supplier quality problem you personally investigated to root cause. What did you find, what corrective action did you drive, and how did you verify that it worked? (4-8 sentences)
• Which supplier quality activities have you owned — supplier corrective action requests, supplier audits or re-evaluations, incoming inspection design, first-article qualification? Name one supplier problem you drove to resolution. (2-4 sentences)
• Have you personally led a nonconformance or CAPA investigation to root cause AND verified the effectiveness of the corrective action — as the owner, not a participant?

Experience:

• Regulated Manufacturing: 3 years (Required)

Ability to Commute:

• Baltimore, MD 21202 (Required)

Work Location: In person

Salary : $95,000 - $115,000