Responsible for the management and technical leadership of the company’s HW/FW/SW activities. Oversee activities pertaining to the design, development, V&V and production processes, materials, quality, and processing equipment. Will possess a hands-on understanding and capability to exercise a broad range of medical device engineering skills/experiences including Quality System requirements and SOPs interfacing directly with production and resolving issues within internal facilities as well as with external engineering firms and suppliers.

Required Skills & Requisites:

• Design and development of electronic hardware & firmware
• Elaboration of system architectures and design documentations with solid troubleshooting experience
• Define, execute and report V&V plans
• Manage area resources optimizing schedules and budgets
• Ensure coordination with other R&D areas including the Quality department for R&D procedures
• Lead transfer activities for manufacturing
• Experience in designing manufacturing tests and quality control electronics
• Internal consulting in documentation, QC, customer support, regulatory approvals
• Integrate the knowledge generated into the company´s management system
• Solid understanding of necessary SW requirements: (modern C/C++, Git version control, task-tracking (e.g. Atlassian Jira), refactoring legacy code or similar)
• Test Driven Development experience (TDD)
• English level C1
• University degree in engineering and/or computer science or equivalent education

 We value:

 Experience in the medical device industry

• Knowledge of professional software engineering & best practices
• Experience in embedded systems
• Experience in Linux OS (CentOS, Debian)
• Experience developing class C software for medical devices according to ISO 62304
• Excellent debugging, communication and interpersonal skills
• Experience with algorithm development

 We offer:

 An exciting opportunity to contribute to a lifesaving device

• Be part of a high-performing team with the challenge of bringing a first-in class device to market
• A project backed by internationally renowned investment partners and scientific advisors
• Competitive economic package

Responsible for the management and technical leadership of the company’s manufacturing activities. Key point of contact for all manufacturing activities. Oversee activities pertaining to the production processes, materials, quality, and processing/testing equipment. Hands-on experience in medical device engineering with manufacturing capabilities from R&D transfer to pilot and flow-line manufacturing in accordance with Quality System requirements and SOPs. Interface directly with internal production teams as well as managing contractors and external engineering partners.

Required Skills & Requisites:

• Successful track record in designing and developing medical devices, ideally up to commercialization; Class III experience, highly desirable
• Minimum 5 yrs direct manufacturing experience in medical mevices, including the assembly of pre-clinical, clinical, and commercial productions
• Experience in assembling single use catheters, as well as electronics & hardware manufacturing
• Deep knowledge in design for manufacturing principles, risk analysis, process FMEA, V&V, design control, yield metrics, COGS as well as test and approval of Document Change Orders (DCO) and Temporary Deviation Notices (TDN).
• Knowledge in techniques with strong quality orientation to automate manual manufacturing processes to increase throughput and COGS.
• Effective interaction with Production, Quality, R&D, Regulatory, and Supply Chain Management; this includes the selection and management of vendors and external partners to ensure required validation, scale-up activities and timelines
• Lead and/or participate in core team meetings to prioritize, plan, schedule and execute improvement projects, focusing on timelines and costs.
• Execute process qualification and validations, including TMVs. (Test Method Validations) for all changes implemented in manufacturing.
• Lead manufacturing with full GMP compliance, quality systems, design Perform troubleshooting on products/process problems as related to design, material, or process. Lead root cause investigation and own CAPA resolutions.
• Control procedures, and applicable international regulatory requirements.
• Ability to work independently with minimal supervision
• University degree in mechanical engineering or equivalent education

 We value:

 Experienced in a startup company environment

• Experience in some or all of the following fields: Electrophysiology, Interventional cardiology, Endovascular therapies, Optical Coherence Tomography (OCT)
• Manufacturing experience with products incorporating optical lenses, optical fibers, and micro assembly

Our client's platform technology enables the efficient delivery of large genes using adeno-associated vectors (AAV). The company overcomes one of the main limitations of AAV, which is their small packaging capacity, allowing the development of treatments for several diseases for which there are currently no treatments. The company has completed the largest Series A financing ever in the Spanish biotech sector.

Our client is looking for a Quality Assurance Manager, with experience in pharma / biotech  who, reporting to the VP of QA & RRAA will be responsible for establishing and developing quality systems and shaping the quality culture of the organization in their headquarters in Barcelona.

Main Responsibilities:

• Establish a culture of compliance and collaboration through the implementation and improvement of quality processes.
• Oversee and manage all GxP Quality tasks with input and support from external QA consultants/specialists as required.
• Lead the development of pharmaceutical quality systems - aligning policies, processes and procedures for internal and outsourced activities.
• Preparation of Quality Documents (e.g. SOPs, Policies, Forms and Templates) in conjunction with Subject Matter Experts as required.
• Assure that all outsourced manufacturing activities and product testing are appropriate and conducted in accordance with company policies and GxP standards.
• Ensure quality agreements with key suppliers and partners are complete, approved and updated at appropriate intervals.
• Provide guidance on investigations and corrective and preventive action (CAPA) plans for compliance issues and/or observations.
• Support development of company training programs for GxP-related procedures, practices and system requirements.
• Remain current with quality management trends and ensure that the company’s quality systems evolve accordingly.
• Lead the Quality Management Review Process.

 Required Qualifications & Experience:

• Degree in biopharma or related field
• Minimum 5+ years in Quality Assurance in the pharma/ biotech industry.
• Experience establishing and/or enhancing development of GxP quality infrastructure and systems compliant with EU and US regulations.
• Experience in overseeing GMP manufacturing activities at CDMOs (experience of Biologics, preferably ATMPs and advantage).
• Experience of GCP and/or GMP inspections.
• Extensive knowledge of EU and US GMP, GCP and GLP.
• Knowledge and experience in negotiating quality agreements and managing vendor relationships and performance.
• Knowledge of quality risk assessment and management methodologies, including successful application and risk remediation an advantage.
• Strong management and interpersonal/communication skills. Prior success in working effectively with senior scientific, medical and operations staff.
• Fluency in English, and Spanish is also preferred.

CHIESI is an innovation-driven multinational pharmaceutical company that annually invests more than 20% of its revenue in R&D. They are actively acquiring new products/companies to support their impressive double-digit growth worldwide.

Rare Diseases is the fastest growing area of the company with an impressive 65% growth last year. To support this strategic business area, CHIESI is looking for an experienced Product Manager to be based at their headquarters in Barcelona.

Main responsibilities:

• Define and present the strategic plan and budget of the assigned portfolio.
• Establish and manage a network of KOLs with Medical Marketing and Sales.
• Lead and coordinate action plans with medical marketing, commercial and market access teams to achieve results agreed in the business plan for the division.
• Understand market dynamics and monitor competitive activities.
• Prepare and support the launch of new Iberia products.
• Develop strategic assessments of the company's products in Spain.
• Participate in marketing projects with HQ

 Required Qualifications & Experience: 

• University degree in Life Sciences.
• MBA or similar degree will be appreciated.
• 3-5 years of marketing experience, preferably in hospital market products, highly valued in rare disease or oncology areas.
• Fluency in English and Spanish required.
• Digital marketing experience a plus.
• Project Management Skills
• Creativity and Innovation
• Flexibility and adaptability

 What we offer: 

• Join a strategic business in a company with 10% annual growth over the last decade.
• Participate in the marketing activities of an exciting growth project in Spain.
• A real opportunity for professional growth.