Senior Engineer, Design Transfer Specialist

BioSpace; Cambridge (MA); On-site; USD 80,000 - 135,000; Full time

Job summary

Join a leading biopharmaceutical company as a Senior Engineer, Design Transfer Specialist, working on the transition of innovative drug delivery devices from development to manufacturing. Ideal candidates possess a strong engineering background, especially in medical device development, and will play a crucial role in streamlining design processes and ensuring compliance with high quality standards.

Benefits

Comprehensive benefits package

Retirement and Savings Plan

Discretionary annual bonus program

Stock-based long-term incentives

Flexible work models

Qualifications

• 10 years of Engineering experience required.
• Experience in medical device development preferred.
• Proficiency in CAD software, especially Solidworks.

Responsibilities

• Develop and execute design transfer plans for drug delivery devices.
• Oversee process validation activities and documentation.
• Collaborate with cross-functional teams for successful design transfer.

Skills

Engineering testing

Analytical skills

Documentation

Collaboration

Process validation

Continuous improvement

Education

Bachelor's degree

Master's degree

Doctorate degree

Tools

Solidworks

Job description

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Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Engineer, Design Transfer Specialist

What You Will Do

Lets do this. Lets change the world. In this vital role you will participate in a technical team towards the successful design, development, and transfer of drug delivery devices. The successful candidate will be responsible for ensuring the seamless transfer of product designs from our development site to various global manufacturing sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key Responsibilities:

• Design Transfer Execution: Develop and execute comprehensive design transfer plans to ensure smooth transition from design to manufacturing. Designs range from single components through full assemblies. Most of the designs will be in polymers.
• Engineering Testing: Responsible for engineering test protocol, execution & report writing, process & test development, prototyping, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
• Documentation: Create and maintain detailed documentation, including design transfer plans, risk management files, and design history files.
• Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure alignment and successful design transfer.
• Vendor Management: manage vendor relationships and ensure compliance with design specifications and regulatory requirements.
• Process Validation: Oversee process validation activities, including equipment and tooling qualification, to ensure manufacturing processes meet design requirements.
• Continuous Improvement: Identify opportunities for process improvements and implement best practices to enhance design transfer efficiency and effectiveness.
  
  
  

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is an individual with these qualifications.

Basic Qualifications

• High school diploma / GED and 10 years of Engineering experience; OR
• Associates degree and 8 years of Engineering experience; Or
• Bachelors degree and 4 years of Engineering experience; Or
• Masters degree and 2 years of Engineering experience; Or
• Doctorate degree
  
  
  

Preferred Qualifications

• 6-8 years of progressive experience as an engineer or scientist in relevant fields (medical device development, manufacturing, etc.)
• Proven track record of executing multiple design or tech transfers.
• 5+ years of project leadership experience in a development, research, or manufacturing environment, ideally with medical devices (Class II and Class III)
• Solid experience in medical device manufacturing and development processes, including experience working under Design Controls
• Demonstrated experience driving CTQ hierarchical decomposition (flow-down) to subsystems and components
• Proficiency in Design for Manufacturing (DfM) and Design for Assembly (DfA)
• Extensive experience in documentation authoring, especially for regulatory compliance and quality management systems
• Strong analytical skills and experience with structured problem-solving approaches
• Excellent communication and presentation skills
• Ability to work within cross-functional and cross-cultural teams
• Extensive device development competences within:
• Design of components for injection molding
• Dimensioning and tolerancing of injection molded components
• Materials science (especially polymers)
• DFM/DFA
• Strong physics/mathematics background
• CAD proficient preferably Solidworks
• Strong interpersonal skills
• Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
• Familiar with the following standards:
• US Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820);
• Needle-based Injection Systems (ISO 11608-1);
• Quality Management (ISO 13485);
• Risk Management (ISO 14971);
• EU Medical Device requirements (Council Directive 93/42/EEC);
• Medical Electrical Equipment (EN 60601)
• Competent in configuration management and change control process/requirements CCB (change control board), CIT (change implementation team) concepts
  
  
  

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible
  
  
  

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

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