Testing Lead

Alvotech -
Stockholm

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9 timmar sedan

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Kvalifikationer

Maskinteknik
Masterexamen
Analytisk förmåga
Kandidatexamen
Kunskap om mekanik

Fullständig jobbeskrivning

Overview of Job Role
Alvotech is looking to hire a Technical Lead to join the Technical Team in Combination Products & Devices department (CPD). The role is based in Stockholm, Sweden. This is an opportunity for an experienced mechanical engineer or similar, with a solid hands on experience from working with design/testing of devices for Needle Injection Systems. You will join a growing local team that will move into new facilities on the Karolinska Institutet Campus.

In this role you will support Alvotech’s ongoing product development programs by preparing and reviewing DHF documentation as technical SME and conducting technical investigations. You will also actively participate in shaping the collaboration both within CPD and across Alvotech functions. As our organization is in an exciting phase of growth and transformation, this role offers a blend of technical execution and strategic influence.

Scope and responsibilities:

Responsible for design verification preparation and testing by serving as the primary point of contact with external contract testing organizations.

Owner ship of the template s for URS/DIR/DV and ensuring compliance with technical s tandards and regulations.

Technical expertise in injection de vice functionality such as component interaction, assembly principles and critical drug-to-device interfaces.

S ubject matter expert reviewer regarding design input/design output in stage reviews following Alvotech’s design control process .

Conduct design impact assessments for proposed design / process updates and supplier initiated changes .

Provide t echnical support in investigations of product quality complaints .

Cross - functional collaboration with Drug Product Development to ensur e form, fit and function of the pre-filled syringe in a drug-device combination .

Support process improvements, including drafting or revising SOPs and contributing to departmental best practices.

Active i nvolvement in the Technical team’s ambition to :

Establish in-house device testing cap abilities (Stockholm).

Improve design transfer and control s trategy planning .

Develop methodology for device platform management, from development to product care.

Job requirements:

Bachelor or Master's degree in mechanical engineering or other relevant scientific or engineering field .

Minimum of 10 years of relevant work experience , of which at least 5 years are fro m medical devices and/or combination products.

Technical analytical skills with a capability to understand and evaluate engineering/test data .

Strong understanding of design control frameworks, including DHF management, design verification/validation, risk management, and usability engineering.

Experience from mechanical testing and test method development is advantageous .

Commitment to contributing to Alvotech’s long term expansion and organisational development .

What we offer:

Meaningful Work: Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people’s lives.

Global Growth: Join a fast-growing, international company with a diverse and inclusive culture.

Collaborative Environment: Work in a positive, flexible, and innovative setting that values teamwork and creativity.

Career Development: Benefit from support for personal growth, internal mobility, and ongoing training opportunities.

Cultural Exchange: Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays.

Well-being & Perks: Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee.

Community & Celebration: Participate in regular social events and celebrate team milestones together.

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