Engineer
Payrate: $40.00- $42.00/hr.
Summary:
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.
Responsibilities:
Preferred Qualifications:
Must Have Skills:
Pay Transparency: The typical base pay for this role across the U.S. is: $40.00- $42.00/hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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 LLCs 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 (url removed).
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 Privacy Policy .
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Summary:
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.
Responsibilities:
- Adheres to strict documentation practices in a GMP regulated environment
- Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
- Authors and reviews technical documentation including protocols, reports, and technical assessments
- Analyze and trend data generated by applying relevant statistical techniques to enable senior staff to make informed decisions
- Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
- Maintains combination product design history files for assigned products
- Develops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
- Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
- Provide general laboratory support including inventory management, sample shipments, and cleanup.
- Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
- Individual contributors with Leadership attributes to effectively represent device engineer within a large network/matrix organization
- At a minimum familiar with the following standards and regulations:
- Quality System Regulation 21CFR820
- Risk Management ISO 14971
- EU Medical Device requirements Council Directive 93/42/EEC
Preferred Qualifications:
- Bachelors Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
- Minimum 2 years of scientific or engineering experience in a GMP regulated environment
- Statistical Analysis software (Minitab or JMP)
- Strong technical writing skills
- CAD fixturing software (SolidWorks)
- Tolerance Stack-Ups (2D, 3D, RSS)
- Instron force tester using Blue Hill Universal
- Experience with design controls; including (but not limited to) verification and design transfer
- Understanding of risk assessments including hazard and probability analysis
- Background in medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
- Ability to work independently and dynamically across functional teams
- Excellent written and verbal communication skills
- Ability to support complex workstreams under demanding timelines
Must Have Skills:
- Technical Writing and Succinct Communication of Technical Topics
- In-Lab Testing
- Tolerance Stack-Ups
Pay Transparency: The typical base pay for this role across the U.S. is: $40.00- $42.00/hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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 LLCs 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 (url removed).
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 Privacy Policy .
#AditiConsulting
#(phone number removed)
