Medical Device Engineer - possible remote (21 CFR 820 / ISO13485)
Streffco Consultants, Inc., is an international staffing and systems integration organization. We provide technology and business operations resources on a project, contract, contract-to-hire or direct hire basis.
Title: Engineer, Medical Device Industrialization
Job ID: 6760
Industry: Biotech/Pharmaceutical
Unit: Technical Development
Location: Cambridge, MA This person can work remotely.
Duration: 12 months Contract
Pay Rate Range: Depends on Experience (W-2 all inclusive rate)
Position
Summary:
Will provide technical oversight of device partners and lead the technology transfer efforts of new combination products and devices. These projects will leverage both internal and external manufacturing sites from clinical development through registration, and provide ongoing commercial support.
Responsibilities:
1. Report to the Senior Engineer, Device Industrialization.
2. Responsible for multi-component drug delivery device assembly scale-up from development through validation and transfer into commercial scale manufacturing.
3. Analyze designs for function, manufacturability, and assembly robustness.
4. Responsible for management of third parties contracted for tool making, injection molding, and manual/automated assembly processes.
5. Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
6. Work with and manage key interfaces and line functions in manufacturing, quality assurance and regulatory to progress device development deliverables.
7. Resolve technical issues during development and manufacturing scale-up.
8. Potential for domestic and International travel up to 10%
Qualifications:
1. 10
years' experience in medical device tooling, injection molding, assembly equipment, and production controls for assembly.
2. Deep understanding of new product introduction, design and development of molded and/or assembled devices & combination products.
3. Deep knowledge of the regulatory and compliance requirements of device design controls and combination products. ( i.e. FDA QSR 21 CFR 820 / ISO13485 quality system requirements)
4. Demonstrated ability to facilitate the interface between the biopharmaceutical company and medical device vendors.
5. Strong understanding and application of validation processes (IQ/OQ/PQ) in combination product device manufacturing.
6. Experience developing multiple device and combination product device products from research through registration and launch.
7. Strong communication, collaboration and team building skills; ability to connect with all levels of the organization.
Education:
Bachelor's Degree in Engineering required. Master 's Degree with Electromechanical or Mechanical experience preferred- plus 10
years' experience.
Please respond by submitting your resume in a Word Document.
(Please include the job title and id# in the subject line)
We will not respond to everyone personally - qualified candidates will be contacted for an interview.Estimated Salary: $20 to $28 per hour based on qualifications.
Title: Engineer, Medical Device Industrialization
Job ID: 6760
Industry: Biotech/Pharmaceutical
Unit: Technical Development
Location: Cambridge, MA This person can work remotely.
Duration: 12 months Contract
Pay Rate Range: Depends on Experience (W-2 all inclusive rate)
Position
Summary:
Will provide technical oversight of device partners and lead the technology transfer efforts of new combination products and devices. These projects will leverage both internal and external manufacturing sites from clinical development through registration, and provide ongoing commercial support.
Responsibilities:
1. Report to the Senior Engineer, Device Industrialization.
2. Responsible for multi-component drug delivery device assembly scale-up from development through validation and transfer into commercial scale manufacturing.
3. Analyze designs for function, manufacturability, and assembly robustness.
4. Responsible for management of third parties contracted for tool making, injection molding, and manual/automated assembly processes.
5. Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
6. Work with and manage key interfaces and line functions in manufacturing, quality assurance and regulatory to progress device development deliverables.
7. Resolve technical issues during development and manufacturing scale-up.
8. Potential for domestic and International travel up to 10%
Qualifications:
1. 10
years' experience in medical device tooling, injection molding, assembly equipment, and production controls for assembly.
2. Deep understanding of new product introduction, design and development of molded and/or assembled devices & combination products.
3. Deep knowledge of the regulatory and compliance requirements of device design controls and combination products. ( i.e. FDA QSR 21 CFR 820 / ISO13485 quality system requirements)
4. Demonstrated ability to facilitate the interface between the biopharmaceutical company and medical device vendors.
5. Strong understanding and application of validation processes (IQ/OQ/PQ) in combination product device manufacturing.
6. Experience developing multiple device and combination product device products from research through registration and launch.
7. Strong communication, collaboration and team building skills; ability to connect with all levels of the organization.
Education:
Bachelor's Degree in Engineering required. Master 's Degree with Electromechanical or Mechanical experience preferred- plus 10
years' experience.
Please respond by submitting your resume in a Word Document.
(Please include the job title and id# in the subject line)
We will not respond to everyone personally - qualified candidates will be contacted for an interview.Estimated Salary: $20 to $28 per hour based on qualifications.
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