Senior Engineer, Design Transfer Specialist

BioSpace

Cambridge (MA)

On-site

USD 90,000 - 120,000

Full time

14 days+

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Benefits offered by this job

Comprehensive benefits package

Retirement and Savings Plan

Flexible work models

Job summary

A leading biotech firm in Cambridge, MA is seeking a Senior Engineer, Design Transfer Specialist. In this role, you will ensure seamless design transition from development to manufacturing while collaborating with cross-functional teams. Ideal candidates possess significant engineering experience and have a strong track record in medical device development. This position offers competitive benefits and opportunities for professional growth.

Qualifications

10+ years engineering experience or equivalent
6-8 years experience in medical device development
Proficiency in regulatory compliance documentation

Responsibilities

Develop design transfer plans for product transitions.
Oversee engineering testing and documentation.
Manage vendor relationships for compliance.

Skills

Engineering experience

Project leadership

Analytical skills

Excellent communication

Interpersonal skills

Education

Bachelor's degree

Master's degree

Doctorate degree

Tools

CAD (Solidworks)

Process validation

Job description

Join to apply for the Senior Engineer, Design Transfer Specialist role at BioSpace

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Join to apply for the Senior Engineer, Design Transfer Specialist role at BioSpace

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.

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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.

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