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| Company Name: |
Pfizer |
| Location: |
Andover, MA |
| Position Type: |
Full Time |
| Post Date: |
03/25/2026 |
| Expire Date: |
04/25/2026 |
| Job Categories: |
Accounting/Auditing, Biotechnology and Pharmaceutical, Engineering, Insurance, Manufacturing and Production, Medical, Writing/Authoring |
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Design Control Engineer II
**ROLE SUMMARY**
This position will be part of BTx Pharmaceutical Research & Development located in St.Louis, MO or Andover, MA. The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle. They will interact with cross functional development teams working with all levels of employees.
**ROLE RESPONSIBILITIES**
+ Ensures that combination product development activities are compliant with quality and regulatory standards - both internal and external.
+ Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
+ Provide input and support for design validation, including but not limited to human factors engineering assessments.
+ Support the generation of all regulatory submission data and content for assigned device projects.
+ Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
+ Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
+ Support internal and external audits of the DPDD Quality System.
**QUALIFICATIONS**
**Must-Have**
+ **BS degree** in appropriate Science & Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 3+ years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.
OR
+ **MS degree** in appropriate Science & Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 0+ years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.
+ Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040 and the EU Medical Devices Directive
+ Working knowledge of EN 62366 and EU Medical Devices Regulation.
+ Capable of working independently with minimal supervision
+ High level of attention to technical details and accuracy.
+ Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
+ Able to work collaboratively in cross functional teams.
+ Excellent communication (e.g. oral, written, presentation) and interpersonal relationship skills.
+ Proficiency in general computer software such as word processing, spreadsheets, presentations.
+ Understand Good Manufacturing Practices (GMP)
**Nice-To-Have**
+ Knowledge of current US and global Regulations, FDA and ICH guidance, ISO standards for syringes/injectors, luer connectors, and quality system regulations (Part 4) for combination products
+ Experience in Design Controls for Combinations Products
+ Device Risk Management expertise
+ Understand statistical sampling plan and statistical analysis of test results.
+ Familiar with Human Factors Engineering - Usability Engineering.
+ Understand project management methodologies and capable to provide technical leadership for projects.
+ Familiar with device assembling manufacturing process
+ Ability to perform mathematical calculations and ability to perform complex data analysis.
**Other Job Details**
+ Relocation support available
+ Work Location Assignment: On Premise
The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
**Sunshine Act**
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
**EEO & Employment Eligibility**
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Research and Development
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| Company Name: |
Pfizer |
| Website: | https://pfizer.dejobs.org/8A96A21C0F73404FAFC059443F65305D25 |
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