Senior Design Engineer - Technical Lead

SHL Medical; Stockholms kommun; Hybrid; SEK 900,000 - 1,200,000; Full time

Benefits offered by this job

Hybrid working policy

Modern Stockholm workplace

Job summary

SHL Medical is seeking a Senior Design Engineer - Technical Lead to drive the evolution of autoinjector platform technologies. You will lead complex mechanical design initiatives, mentor engineers, and ensure platform solutions are robust, scalable, and compliant in a regulated environment.

You will collaborate with Manufacturing, Quality, Regulatory Affairs, and Human Factors to translate technical challenges into innovative solutions that improve performance, reliability, manufacturability,

Qualifications

• 5+ years’ relevant experience in medical device design or other strongly regulated industry.
• Excellent CAD (SolidWorks), simulation software, and statistical analysis skills.
• Strong DFx experience and willingness to drive optimal design for all stakeholders.
• Fluency in English.

Responsibilities

• Lead the mechanical design and technical development of one autoinjector platform, ensuring solutions meet performance, quality, manufacturability, sustainability, and cost requirements.
• Provide technical leadership across platform development and lifecycle management activities.
• Mentor and support Design Engineers to deliver robust, scalable platform solutions.
• Drive continuous improvement by evaluating product, manufacturing, and market feedback.
• Lead feasibility studies, simulations, and testing to validate design concepts.
• Identify technical risks and opportunities and develop mitigation strategies.
• Ensure compliance with regulatory requirements, standards, and quality processes.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, Human Factors, Testing, and other engineering teams.
• Act as a subject matter expert for the platform and influence technical strategy.
• Maintain platform design documentation and support lifecycle activities in a regulated environment.

Skills

SolidWorks

Simulation

Statistics

Six Sigma

Systems Engineering

Leadership

English

Tools

CAD modelling

Tolerance analysis

FEA simulations

FMEA

FTA

Risk management

Job description

About The Company

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

At SHL Medical, we're shaping the future of self-injection solutions used by patients around the world. As a Senior Design Engineer - Technical Lead, you will play a key role in the evolution of one of our autoinjector platform technologies, driving technical excellence across both new development and lifecycle management activities. In this role, you will lead complex mechanical design initiatives, guide engineering decisions, and mentor fellow engineers while ensuring our platform solutions remain robust, scalable, compliant, and competitive. Working closely with cross-functional experts across engineering, manufacturing, quality, regulatory affairs, and human factors, you will translate technical challenges into innovative solutions that enhance product performance, reliability, manufacturability, and sustainability.

Main Responsibilities

• Lead the mechanical design and technical development of one of SHL Medical's autoinjector platforms, ensuring solutions meet performance, quality, manufacturability, sustainability, and cost requirements.
• Provide technical leadership across platform development and lifecycle management activities, guiding engineering decisions and driving design excellence.
• Mentor and support Design Engineers, fostering a collaborative engineering culture and enabling the delivery of robust, scalable platform solutions.
• Drive continuous improvement initiatives by evaluating product, manufacturing, and market feedback to enhance device performance, reliability, safety, and competitiveness.
• Lead feasibility studies, engineering evaluations, simulations, and testing activities to assess new technologies and validate design concepts.
• Identify technical risks and opportunities, using data-driven analysis and sound engineering judgement to develop effective solutions and mitigation strategies.
• Ensure compliance with applicable regulatory requirements, industry standards, and quality processes, including design controls, risk management, verification, validation, and change management activities.
• Collaborate closely with cross-functional teams including Manufacturing, Quality, Regulatory Affairs, Human Factors, Testing, and other engineering disciplines to deliver platform objectives.
• Act as a subject matter expert for the platform, influencing technical strategy and partnering with internal and customer-facing stakeholders to achieve successful product outcomes.
• Maintain platform design documentation and support root cause investigations, product updates, and lifecycle activities in a regulated environment.

Minimum Requirements

• Senior Design Engineer for injection molding-based products with 5+ years’ relevant experience in medical industry or strongly regulated industry
• Excellent skills in CAD (Solidworks), simulation software, and statistical analysis.
• Strong DFx experience (Design for Testing, Manufacturing, Assembly, Quality, Cost, Sustainability) and willingness to drive the design for optimum solutions in consideration of all stakeholder needs
• Strong willingness to evaluate, apply and champion modern tools and methods for design excellence such as Six Sigma and Systems Engineering concepts
• Experienced to lead designers to realize complex design solutions
• Fluency in English

Preferred Requirements

• Experience with engineering design methodologies and tools, including 3D/2D CAD modelling, tolerance analysis, FEA simulations, and risk management techniques such as FMEA and FTA.
• Experience working within regulated product development environments and applying standards such as ISO 13485, ISO 14971, IEC 62366, and FDA combination product regulations.
• Knowledge of platform development, systems engineering principles, and their application to medical device design.
• Experience leading complex engineering projects and supporting multiple development activities simultaneously.
• Strong problem-solving skills, with the ability to analyse complex technical challenges and develop pragmatic, data-driven solutions.
• Excellent communication skills and the ability to translate complex technical information into clear recommendations for diverse stakeholders.
• Experience driving continuous improvement initiatives focused on product performance, quality, manufacturability, sustainability, or cost optimisation.
• Knowledge of needle-based injection systems and ISO 11608-1 would be advantageous.

We Offer

• A company culture Focusing on our Customers, Operating with Ethics and Integrity, Driving Simplicity, Learning, Improving & Delivering Together.
• Challenging assignments in a fast growing and innovative industry.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy.
• A modern working environment in Nacka Strand, Stockholm, with multicultural and motivated teams.

For more information on SHL Medical, please visit: shl-medical.com

Please note: We do not accept applications from recruitment agencies for this role.