Engineer 2, Sustaining, R&D

Jobtailor; Wyomissing (Berks County); On-site; USD 65,000 - 95,000; Full time

Job summary

Jobtailor in Wyomissing, PA is seeking a Biomedical/Mechanical Engineer to join our medical device team. You will support design verification, risk management, and design controls, translating user needs into robust product improvements while ensuring ISO 13485 and FDA 21 CFR 820 compliance.

Collaborating with process development, regulatory, and manufacturing, you will contribute to DFMEA, CAPA, DMR updating, and documentation.

Qualifications

• BS in Engineering or equivalent technical discipline.
• Familiarity with design control processes and regulatory requirements (ISO 13485, FDA 21 CFR 820).
• Exposure to risk management and verification/validation principles (ISO 14971).
• Ability to perform basic statistical analyses using Minitab or equivalent software.
• Understanding of manufacturability and ergonomic considerations in medical device design.

Responsibilities

• Assist in market segment analysis to inform product positioning and improvements.
• Support evaluations and clinical interactions to understand user needs and workflows.
• Provide engineering support for product demonstrations and troubleshooting.
• Contribute to design verification and validation activities, including test protocols.
• Assist in DFMEA, UFMEA, and hazard analysis under senior engineers.
• Support documentation updates (DHF/DMR) ensuring ISO 13485 and FDA 21 CFR 820 compliance.
• Collaborate with manufacturing to ensure design outputs meet production requirements.
• Participate in sustaining engineering and implement design improvements.
• Work with regulatory teams to ensure changes meet compliance requirements.
• Support process validation studies (IQ, OQ, PQ) and process control improvements.
• Assist in CAPA and non-conformance resolution efforts.
• Develop familiarity with SAP, Agile PLM, and quality systems for changes and doc management.
• Prepare technical reports summarizing tests, analyses, and change justifications.
• Contribute to product labeling verification and engineering change requests.

Skills

Mechanical systems understanding

Fluid dynamics understanding

Material properties knowledge

Statistical analysis (Minitab)

Education

BS in Engineering

Tools

SolidWorks

3D modeling

2D drawings

Minitab

Job description

Responsibilities

• Assist in analyzing market segments and competitive products to understand product positioning and identify areas for improvement.
• Support product evaluations and clinical interactions to understand user needs, device applications, and clinical workflows.
• Provide engineering support for product demonstrations, basic clinician interactions, and product troubleshooting.
• Apply engineering principles to evaluate product design changes, ensuring compliance with regulatory and quality standards.
• Contribute to design verification and validation activities, including developing test protocols, executing tests, and analyzing results.
• Assist in risk management activities, including DFMEA, UFMEA, and hazard analysis, under the guidance of senior engineers.
• Support design documentation, including updating Design History Files (DHF) and Device Master Records (DMR), ensuring compliance with ISO 13485 and FDA 21 CFR 820 requirements.
• Collaborate with process development teams to ensure design outputs are compatible with manufacturing requirements and scalability.
• Participate in sustaining engineering activities such as troubleshooting product performance issues, implementing design improvements, and ensuring manufacturability.
• Work with regulatory teams to ensure product changes and updates meet compliance requirements.
• Support the execution of process validation studies (IQ, OQ, PQ) and contribute to process control improvements.
• Assist in root cause analysis, CAPA, and non-conformance resolution efforts.
• Develop familiarity with SAP, Agile PLM, and quality systems to support engineering changes, product tracking, and documentation management.
• Engage in technical report writing, including summarizing test data, engineering analysis, and change justifications.
• Contribute to product labeling verification, documentation updates, and engineering change requests (ECRs) as part of sustaining efforts.
• Collaborate with supply chain and operations teams to ensure smooth implementation of design changes and material substitutions.
• Participate in technical discussions, cross-functional meetings, and project team collaborations to support business objectives.

Requirements

• BS in Engineering, or equivalent technical discipline.
• Minimum of 2 years of previous experience in a related field (e.g., medical device design and manufacturing, or similar regulated industry, plastic processing, injection molding).
• Basic understanding of mechanical systems, fluid dynamics, and material properties related to vascular access devices.
• Familiarity with CAD modeling (SolidWorks) and ability to create and modify 3D models and 2D drawings.
• Awareness of Design for Manufacturability (DFM) principles and basic ergonomic considerations in medical device design.
• Understanding of verification and validation principles, including ISO 14971 risk management.
• Ability to perform basic statistical analyses using Minitab or equivalent software.
• Exposure to design control processes and regulatory requirements, including ISO 13485 and FDA 21 CFR 820.

Certifications & Qualifications

• BS in Engineering
• ISO 14971