Overview
On Site
$42 - $44 hr
Contract - W2
Contract - Independent
Contract - 12+ mo(s)
Skills
COMBINATION PRODUCTS
COMBINATION PRODUCT
ELECTROMECHANICAL
ELECTRO-MECHANICAL
MEDICAL DEVICES
MEDICAL DEVICE
PHARMA
PHARMACEUTICAL
DRUG DELIVERY
DESIGN CONTROL
13485
CFR
DFMEA
PFMEA
VERIFICATION
VALIDATION
TESTING
TEST
TESTED
STATISTICAL
MINITAB
SMARTSHEET
SMART SHEET
Job Details
Payrate: $42.00 - $44.00/hr.
Summary:
We are seeking a contract electromechanical combination product Sr. Engineer. The Sr. Engineer will lead and support design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.
Responsibilities:
Preferred Qualifications:
Top 3 Must Have Skill Sets:
Nice to have:
Pay Transparency: The typical base pay for this role across the U.S. is: $42.00 - $44.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying STOP to messages or by contacting .
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our
#AditiConsulting
#25-23628
Summary:
We are seeking a contract electromechanical combination product Sr. Engineer. The Sr. Engineer will lead and support design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.
Responsibilities:
- Provide design verification support for combination products, ensuring compliance with Quality System Requirements, Design Control (21 CFR 820.30), and ISO 13485.
- Lead and execute on-site testing and verification activities for electromechanical delivery systems and related platforms.
- Develop, review, and execute test protocols, reports, and technical documentation in accordance with design control and regulatory expectations.
- Perform data verification, analysis, and traceability reviews to ensure product performance meets user needs and design inputs.
- Manage materials and maintain traceability of material inventory at Company to support various design control activities. Additionally, support supply of the materials as required to internal and external sites.
- Partner cross-functionally with R&D, Human Factors, Quality, Regulatory, and Manufacturing teams to drive design robustness, risk mitigation, and design transfer readiness.
- Support control plans, requirements management, and risk management activities (DFMEA, PFMEA) as part of design verification strategy.
- Contribute to continuous improvement of test methods, design verification processes, and documentation practices in line with Company s device development framework.
- Manage change assessments driven by internal and external changes during the life cycle of the combination product
- Participate in and support cross-functional design reviews for combination product development.
Preferred Qualifications:
- Master s or Bachelor s Degree in Engineering Discipline (Mechanical, Biomedical, Electrical) with 5-7 years (or 3-5 years with Masters) of professional experience in highly regulated environment (strong preference for medical device, biopharma and/or combination product experience).
- Experience with electromechanical systems, injection devices, or delivery platforms preferred.
- Demonstrated expertise in design verification testing, data analysis, and protocol/report generation under design control.
- Strong understanding of materials coordination, supplier interaction, and lab testing logistics.
- Proven ability to work in cross-functional project teams, communicate technical results clearly, and lead execution to meet program milestones.
- Working proficiency in statistical analysis software (Minitab)
- Smartsheets proficiency is a plus.
- Ability to work independently and dynamically across functional teams
- Excellent written and verbal communication skills
- Must be capable of working on multiple projects in a deadline driven environment.
Top 3 Must Have Skill Sets:
- Expertise in design control and quality systems (21 CFR 820.30, ISO 13485) with proven ability to plan, execute, and document design verification and validation for combination products.
- Hands-on capability in testing electromechanical systems, including data collection, statistical analysis, and performance evaluation.
- Proven ability to partner effectively with R&D, Quality, Regulatory, and Manufacturing teams.
Nice to have:
- Minitab
- Smartsheet
- Supplier interaction experience
Pay Transparency: The typical base pay for this role across the U.S. is: $42.00 - $44.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying STOP to messages or by contacting .
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our
#AditiConsulting
#25-23628
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.